{"studies":[
{"protocolSection":{"identificationModule":{"nctId":"NCT07822399","orgStudyIdInfo":{"id":"CP-MGC030-01"},"organization":{"fullName":"MacroGenics","class":"INDUSTRY"},"briefTitle":"A Study of MGC030 in Participants With Advanced Solid Tumors","officialTitle":"A Phase 1, First-in-Human, Open Label, Dose Escalation, Dose Optimization, and Cohort Expansion Study of MGC030 in Participants With Advanced Solid Tumors"},"statusModule":{"statusVerifiedDate":"2026-10","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2026-10-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2028-09","type":"ESTIMATED"},"completionDateStruct":{"date":"2029-03","type":"ESTIMATED"},"studyFirstSubmitDate":"2026-09-10","studyFirstSubmitQcDate":"2026-09-10","studyFirstPostDateStruct":{"date":"2026-09-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-10-27","lastUpdatePostDateStruct":{"date":"2026-10-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"MacroGenics","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of MGC030. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors of select types.\n\nThe main question the study aims to answer is:\n\n* What types of side effects will participants experience when receiving MGC030?\n* Can MGC030 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors? Participants will\n* Undergo screening procedures to determine eligibility\n* Receive study treatments initially every 3 weeks.\n* Have blood samples taken for routine and research tests\n* Have other examinations to check heart and lung function, and general health status\n* Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary.\n* Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment."},"conditionsModule":{"conditions":["Urothelial Cancer","GastroEsophageal Cancer","Colorectal Cancer","Esophageal Cancer","Gastric Cancer (GC)","Pancreatic Cancer"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":314,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Dose escalation Cohort 1","type":"EXPERIMENTAL","description":"MGC030 Dose Level 1","interventionNames":["Biological: MGC030"]},{"label":"Dose escalation Cohort 2","type":"EXPERIMENTAL","description":"MGC030 Dose Level 2","interventionNames":["Biological: MGC030"]},{"label":"Dose escalation Cohort 3","type":"EXPERIMENTAL","description":"MGC030 Dose Level 3","interventionNames":["Biological: MGC030"]},{"label":"Dose escalation Cohort 4","type":"EXPERIMENTAL","description":"MGC030 Dose Level 4","interventionNames":["Biological: MGC030"]},{"label":"Dose escalation Cohort 5","type":"EXPERIMENTAL","description":"MGC030 Dose Level 5","interventionNames":["Biological: MGC030"]},{"label":"Dose escalation Cohort 6","type":"EXPERIMENTAL","description":"MGC030 Dose Level 6","interventionNames":["Biological: MGC030"]},{"label":"Dose Optimization Cohort 1","type":"EXPERIMENTAL","description":"Dose Optimization Dose Level 1","interventionNames":["Biological: MGC030"]},{"label":"Dose Optimization Cohort 2","type":"EXPERIMENTAL","description":"Dose Optimization Dose Level 2","interventionNames":["Biological: MGC030"]},{"label":"Expansion Cohort 1","type":"EXPERIMENTAL","description":"Recommended dose for expansion","interventionNames":["Biological: MGC030"]},{"label":"Expansion Cohort 2","type":"EXPERIMENTAL","description":"Recommended dose for expansion","interventionNames":["Biological: MGC030"]},{"label":"Expansion Cohort 3","type":"EXPERIMENTAL","description":"Recommended dose for expansion","interventionNames":["Biological: MGC030"]},{"label":"Expansion Cohort 4","type":"EXPERIMENTAL","description":"Recommended dose for expansion","interventionNames":["Biological: MGC030"]},{"label":"Expansion Cohort 5","type":"EXPERIMENTAL","description":"Recommended dose for expansion","interventionNames":["Biological: MGC030"]}],"interventions":[{"type":"BIOLOGICAL","name":"MGC030","description":"Antibody-drug conjugate","armGroupLabels":["Dose Optimization Cohort 1","Dose Optimization Cohort 2","Dose escalation Cohort 1","Dose escalation Cohort 2","Dose escalation Cohort 3","Dose escalation Cohort 4","Dose escalation Cohort 5","Dose escalation Cohort 6","Expansion Cohort 1","Expansion Cohort 2","Expansion Cohort 3","Expansion Cohort 4","Expansion Cohort 5"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to dose interruption, AEs leading to dose reduction or treatment discontinuation, does limiting toxicities and AEs of special interest.","timeFrame":"Throughout the study, estimated duration 2 years."}],"secondaryOutcomes":[{"measure":"Mean concentrations MGC030 antibody-drug conjugate, total antibody and unconjugated payload.","timeFrame":"Throughout the study treatment period, up to 2 years"},{"measure":"Number of Participants Who Develop Anti-Drug Antibodies to MGC030","timeFrame":"Throughout the study treatment period, up to 2 years"},{"measure":"Objective response rate","description":"The ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is estimated as the proportion of participants in the Response Evaluable Population who achieve Best Overall Response of Complete Response or Partial Response.","timeFrame":"Throughout the study treatment period, up to 2 years"},{"measure":"Duration of Response","description":"DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first.","timeFrame":"Throughout the study treatment period, up to 2 years."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participants in dose escalation cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: urothelial cancer, colorectal cancer (CRC), gastric or gastroesophageal junction (GEJ) cancer, esophageal cancer, or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.\n* Participants in expansion cohorts must have histologically proven, unresectable, locally advanced or metastatic solid tumors\n\n  * Urothelial cancer with progression following platinum-containing chemotherapy for metastatic or locally advanced/unresectable cancer, or within 12 months from completion of neo-adjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive cancer.\n  * Gastric/GEJ carcinoma with progression during or following at least 1 systemic therapy.\n  * Esophageal cancer with progression during or following at least 1 systemic therapy.\n  * CRC with progression during or following treatment with at least 2 prior lines of systemic therapy (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease.\n\n    * CRC harboring an activating EGFR mutation must have progressed during or following at least one EGFR targeted therapy, if available.\n    * Participants should have received no more than 4 prior lines of systemic therapy for advanced or metastatic disease.\n  * Pancreatic cancer with progression during or following at least 1 systemic therapy. Participants should have received no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.\n* Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.\n* Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.\n* Participants have acceptable physical condition and laboratory values.\n* Participants of childbearing potential must agree to use highly effective methods of birth control.\n* Participants must not be pregnant, planning to be pregnant, or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Active brain metastases or leptomeningeal metastases.\n* Prior stem cell, tissue, or solid organ transplant.\n* Another malignancy that required treatment within the past 2 years, with the exception of those with a negligible risk of metastasis or death such as adequately treated non-melanomatous skin cancer, localized prostate cancer (Gleason Score \\< 6), or carcinoma in situ.\n* History of primary immunodeficiency.\n* Active viral, bacterial, or fungal infection\n* Prior treatment with Topoisomerase 1-based ADCs for cancer.\n* Prior treatment with major surgery, mediastinal or lung radiation, vaccination with live virus vaccines, systemic cancer treatment, chimeric antigen receptor (CAR)-T cell therapy, or experimental treatment within 4 weeks of the start of study treatment.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Global Trial Manager","role":"CONTACT","phone":"301-251-5172","email":"info@macrogenics.com"}],"overallOfficials":[{"name":"Frank Perabo, MD, PhD","affiliation":"MacroGenics","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"START New York-Long Island","status":"RECRUITING","city":"Lake Success","state":"New York","zip":"11042","country":"United States","contacts":[{"name":"Geraldine O'Sullivan Coyne","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":40.77066,"lon":-73.71763}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-30"},"conditionBrowseModule":{"meshes":[{"id":"D015179","term":"Colorectal Neoplasms"},{"id":"D004938","term":"Esophageal Neoplasms"},{"id":"D013274","term":"Stomach Neoplasms"},{"id":"D010190","term":"Pancreatic Neoplasms"}],"ancestors":[{"id":"D007414","term":"Intestinal Neoplasms"},{"id":"D005770","term":"Gastrointestinal Neoplasms"},{"id":"D004067","term":"Digestive System Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D003108","term":"Colonic Diseases"},{"id":"D007410","term":"Intestinal Diseases"},{"id":"D012002","term":"Rectal Diseases"},{"id":"D006258","term":"Head and Neck Neoplasms"},{"id":"D004935","term":"Esophageal Diseases"},{"id":"D013272","term":"Stomach Diseases"},{"id":"D004701","term":"Endocrine Gland Neoplasms"},{"id":"D010182","term":"Pancreatic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]}},"hasResults":false},
{"protocolSection":{"identificationModule":{"nctId":"NCT07715747","orgStudyIdInfo":{"id":"TJ037130STM101"},"organization":{"fullName":"TJ Biopharma Co., Ltd.","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors","officialTitle":"Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors"},"statusModule":{"statusVerifiedDate":"2026-10","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2026-08-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2028-06-30","type":"ESTIMATED"},"completionDateStruct":{"date":"2028-06-30","type":"ESTIMATED"},"studyFirstSubmitDate":"2026-07-16","studyFirstSubmitQcDate":"2026-07-16","studyFirstPostDateStruct":{"date":"2026-07-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-10-28","lastUpdatePostDateStruct":{"date":"2026-10-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"TJ Biopharma Co., Ltd.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The goal of this clinical trial is to evaluate the safety and tolerability of TJ037130 in participants with advanced or metastatic solid tumors, and to determine the Potential Optimal Biological Dose (POBD) of TJ037130 for subsequent investigations."},"conditionsModule":{"conditions":["Solid Tumor","Metastatic Ovary Cancer","Metastatic Gastric Cancer","Metastatic Endometrial Carcinoma"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NA","interventionModel":"SEQUENTIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":128,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"TJ037130","type":"EXPERIMENTAL","interventionNames":["Drug: TJ037130"]}],"interventions":[{"type":"DRUG","name":"TJ037130","description":"Dose Escalation:TJ037130 will be administered at up to 5 dose levels(0.75,2,5,10 and 18mg/kg) once 3 weeks(Q3W); During dose expansion, TJ037130 will be administered once 3 weeks in 4 Cohorts.","armGroupLabels":["TJ037130"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Incidence,type,severity and correlation with study treament of AEs","timeFrame":"Up to 90 days post last dose"}],"secondaryOutcomes":[{"measure":"Pharmacokinetic (PK) Parameters: AUCt","timeFrame":"Up to 90 days post last dose"},{"measure":"Pharmacokinetic (PK) Parameters: Cmax","timeFrame":"Up to 90 days post last dose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Males or females aged 18 years or older;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* Voluntarily enroll in the study and be able to comply with scheduled visits, treatment schedules, laboratory tests and other study procedures;\n* Participants with histologically and/or cytologically confirmed recurrent or metastatic advanced malignant tumors for whom no standard therapy with clinical benefit is available, or who are ineligible for existing standard treatment regimens. Claudin 6 (CLDN6) positive expression confirmed by immunohistochemistry (IHC) ;\n* Agree to provide archived tumor tissue or fresh biopsy tumor samples (not mandatory during the dose escalation phase);\n* Have at least one evaluable tumor lesion per RECIST Version 1.1 (dose escalation phase); have at least one measurable tumor lesion per RECIST Version 1.1 (dose expansion phase);\n* All acute adverse events resulting from prior anticancer therapies have resolved to Grade ≤ 1 or baseline per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (excluding toxicities judged by the Investigator to pose no safety risk, such as alopecia, peripheral neurotoxicity, hypothyroidism stabilized with hormone replacement therapy, etc.);\n* Be deemed an appropriate candidate for this clinical trial by the Investigator with an expected survival of ≥ 12 weeks;\n* Demonstrate adequate organ function within 7 days prior to the first dose of study drug;\n* Male and female participants of childbearing potential must agree to use two forms of effective contraception throughout the study period and for 6 months after the last dose of TJ037130. In addition, female participants of childbearing potential must have a negative serum or urine pregnancy test.\n\nExclusion Criteria:\n\n* Prior exposure to CLDN6-targeted therapy;\n* Prior exposure to 4-1BB agonists;\n* Received PD-1/PD-L1 therapy or other immune checkpoint inhibitors/agonists within 28 days prior to the first dose of study drug;\n* History of a second malignancy within the past 3 years, except cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma, or carcinoma in situ of the cervix;","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Lina Qin","role":"CONTACT","phone":"+86-18600672907","email":"lina.qin@tjbio.com"},{"name":"Liting Liu","role":"CONTACT","phone":"+86-15026781022","email":"liting.liu@tjbio.com"}],"locations":[{"facility":"Shanghai GoBroad Cancer Hospital","status":"RECRUITING","city":"Shanghai","state":"Shanghai Municipality","country":"China","contacts":[{"name":"Jin Li, Docotor","role":"CONTACT"}],"geoPoint":{"lat":31.22222,"lon":121.45806}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-30"},"conditionBrowseModule":{"meshes":[{"id":"D010051","term":"Ovarian Neoplasms"},{"id":"D013274","term":"Stomach Neoplasms"},{"id":"D016889","term":"Endometrial Neoplasms"}],"ancestors":[{"id":"D004701","term":"Endocrine Gland Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D010049","term":"Ovarian Diseases"},{"id":"D000291","term":"Adnexal Diseases"},{"id":"D005831","term":"Genital Diseases, Female"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D005833","term":"Genital Neoplasms, Female"},{"id":"D014565","term":"Urogenital Neoplasms"},{"id":"D000091662","term":"Genital Diseases"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D006058","term":"Gonadal Disorders"},{"id":"D005770","term":"Gastrointestinal Neoplasms"},{"id":"D004067","term":"Digestive System Neoplasms"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D013272","term":"Stomach Diseases"},{"id":"D014594","term":"Uterine Neoplasms"},{"id":"D014591","term":"Uterine Diseases"}]}},"hasResults":false},
{"protocolSection":{"identificationModule":{"nctId":"NCT07780305","orgStudyIdInfo":{"id":"ABCSG R07"},"organization":{"fullName":"Austrian Breast & Colorectal Cancer Study Group","class":"NETWORK"},"briefTitle":"ABCSG R07 Rectal Cancer Registry","officialTitle":"ABCSG R07 Rectal Cancer Registry (RCR) - Multicenter Retrospective and Prospective Analysis of Patients With Localized, Non-metastatic Rectal Cancer in Austria","acronym":"ABCSG R07 RCR"},"statusModule":{"statusVerifiedDate":"2026-10","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2026-09-16","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2033-02-01","type":"ESTIMATED"},"completionDateStruct":{"date":"2033-02-01","type":"ESTIMATED"},"studyFirstSubmitDate":"2026-08-19","studyFirstSubmitQcDate":"2026-08-19","studyFirstPostDateStruct":{"date":"2026-08-21","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-10-29","lastUpdatePostDateStruct":{"date":"2026-10-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Austrian Breast & Colorectal Cancer Study Group","class":"NETWORK"},"collaborators":[{"name":"GlaxoSmithKline","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"In Austria, patients with rectal cancer that has not spread to other parts of the body are typically treated with either total neoadjuvant therapy (TNT) or immunotherapy, depending on their microsatellite status (DNA repair capacity).\n\nHowever, treatment can vary considerably between hospitals in Austria. These differences may include the type and duration of treatment, as well as the active ingredients used. There are currently no clear recommendations on which exact treatment is best for each specific case.\n\nThe aim of this observational study is to collect information on the different treatments used in Austria for patients with localized rectal cancer and to document the outcomes of these treatments.\n\nOnly information and samples collected as part of the patients' routine care will be used for the study. Participation in the study will not change or affect the treatment chosen by the treating physician.","detailedDescription":"The purpose of this observational study is to establish a registry for locally advanced rectal adenocarcinoma. This registry will document the treatment regimens of participants receiving \"total neoadjuvant therapy (TNT)\" as well as those with dMMR/MSI-H disease.\n\nThe ABCSG R07 Rectal Cancer Registry (RCR) study will provide real-world data that reflect the current therapeutic landscape for participants. Participants who are either treated with \"total neoadjuvant therapy (TNT)\" or those with dMMR/ MSI-H disease, as well as their response to the respective standard therapy, will be documented.\n\n\"Total neoadjuvant therapy (TNT)\" is the preferred treatment option for locally advanced rectal adenocarcinoma; however, treatment is carried out according to a different TNT protocol at each hospital or institute.\n\nSince the observational study does not interfere with the course of treatment, neither additional health risks nor any individual benefit from participation in the non-interventional study is to be expected.\n\nThis study is being conducted at approx. 6 study sites in Austria, and a total of about 600 participants (retrospective and prospective) will take part. The treating physician selects the treatment/therapy that she/he considers most appropriate for the participant. In the retrospective part participants with localized, non-metastatic rectal cancer treated with total neoadjuvant therapy or participants with dMMR/MSI-H status irrespective of treatment between June 2020 (or June 2005 for dMMR/MSI-H cohort,) and start of this non-interventional study will be enrolled.\n\nIn the prospective part participants with localized, non-metastatic rectal cancer treated with total neoadjuvant therapy or participants with dMMR/MSI-H status irrespective of treatment between start of this non-interventional study and three years thereafter will be enrolled."},"conditionsModule":{"conditions":["Rectal Cancer","Adenocarcinoma of Rectum"],"keywords":["Rectal","cancer","registry","total neoadjuvant therapy","mismatch repair-deficient","locally advanced rectal cancer","Non-interventional study","adenocarcinoma"]},"designModule":{"studyType":"OBSERVATIONAL","patientRegistry":true,"targetDuration":"3 Years","designInfo":{"observationalModel":"COHORT","timePerspective":"OTHER"},"bioSpec":{"retention":"SAMPLES_WITH_DNA","description":"* Blood: whole blood or plasma\n* Tissue: FFPE"},"enrollmentInfo":{"count":600,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Retrospective part","description":"Participants treated between June 2020 and study start. For dMMR/MSI-H cohort: treated between June 2005 until study start"},{"label":"Prospective part","description":"Participants treated between study start and three years after study start"}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Treatment Responses (clinical standard therapy)","description":"Recording of treatment responses according to clinical standard therapy.","timeFrame":"At the time of surgery"}],"secondaryOutcomes":[{"measure":"Proportion of different TNT concepts used","description":"Treatment details","timeFrame":"From therapy start to Surgery"},{"measure":"Proportion of participants using immunotherapy","timeFrame":"From therapy start to Surgery"},{"measure":"Proportion of participants using watch & wait therapy","timeFrame":"At surgery visit"},{"measure":"Proportion of the surgical techniques used","timeFrame":"At surgery"},{"measure":"Proportion of locoregional recurrences","timeFrame":"From therapy start until 3 years from re-staging or end of primary treatment"},{"measure":"Proportion of the participants with distant metastases","timeFrame":"From therapy start until 3 years from re-staging or end of primary treatment"},{"measure":"Event-free survival (EFS)","description":"EFS includes locoregional event, distant metastasis and death","timeFrame":"From therapy start until 3 years from re-staging or end of primary treatment"},{"measure":"TME-free survival in watch & wait group","timeFrame":"From therapy start until 3 years from re-staging or end of primary treatment"},{"measure":"Overall survival (OS)","timeFrame":"From therapy start until 3 years from re-staging or end of primary treatment"},{"measure":"Locoregional event-free survival (LREFS)","description":"locoregional progression, recurrence, regrowth or death","timeFrame":"From therapy start until 3 years from re-staging or end of primary treatment"},{"measure":"Distant metastasis-free survival (DMFS)","timeFrame":"From therapy start until 3 years from re-staging or end of primary treatment"},{"measure":"Charlson Comorbidity Index (CCI) Score prior to any treatment start","timeFrame":"Baseline"},{"measure":"ECOG performance status at diagnosis","timeFrame":"Diagnosis"},{"measure":"Proportion of resection rates","timeFrame":"Surgery"},{"measure":"Treatment adherence","timeFrame":"From therapy start until surgery"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Female and male participants with age \\>= 18 years\n* Signed informed consent obtained prior to registration of the participant.\n* Localized rectal cancer treated with TNT or localized, non-metastatic dMMR/MSI-H rectal cancer, irrespective of treatment\n\nExclusion Criteria:\n\n* Distant metastases at primary diagnosis","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"],"studyPopulation":"Multicenter study in Austria of patients with localized non-metastatic rectal cancer treated with total neoadjvuant therapy or dMMR/MSI-H status","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"centralContacts":[{"name":"Miriam Muehlburger, MSc","role":"CONTACT","phone":"+43 1 4089230","email":"miriam.muehlburger@abcsg.at"}],"overallOfficials":[{"name":"Falk Roeder, Prof, MD","affiliation":"Paracelsius Medical University Salzburg","role":"STUDY_CHAIR"},{"name":"Gudrun Piringer, MD, MSc","affiliation":"Johannes Kepler University Linz","role":"STUDY_CHAIR"},{"name":"Lukas Weiss, Prof, MD","affiliation":"Paracelsius Medical University Salzburg","role":"STUDY_CHAIR"}],"locations":[{"facility":"Universitätsklinikum Wiener Neustadt, Abteilung für Innere Medizin, Hämatologie und int. Onkologie","status":"NOT_YET_RECRUITING","city":"Wiener Neustadt","state":"Lower Austria","zip":"2700","country":"Austria","contacts":[{"name":"Birgit Grünberger, MD, Head","role":"CONTACT","email":"birgit.gruenberger@wienerneustadt.lknoe.at"},{"name":"Birgit Grünberger, MD, Head","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.80485,"lon":16.23196}},{"facility":"LKH Salzburg-PMU, Univ. Klinik f. Innere Med III","status":"RECRUITING","city":"Salzburg","state":"State of Salzburg","zip":"5020","country":"Austria","contacts":[{"name":"Lukas Weiss, MD, Prof.","role":"CONTACT","phone":"+4357255","phoneExt":"25804","email":"lu.weiss@salk.at"},{"name":"Lukas Weiss, MD, Prof.","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.79941,"lon":13.04399}},{"facility":"Med. University Graz, Oncology","status":"NOT_YET_RECRUITING","city":"Graz","state":"Styria","zip":"8036","country":"Austria","contacts":[{"name":"Jakob Riedl, MD","role":"CONTACT","email":"j.riedl@medunigraz.at"},{"name":"Jakob Riedl, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.06733,"lon":15.44197}},{"facility":"Medical University Innsbruck, Internal Medicine V","status":"NOT_YET_RECRUITING","city":"Innsbruck","state":"Tyrol","zip":"6020","country":"Austria","contacts":[{"name":"Arno Amann, MD","role":"CONTACT","email":"arno.amann@tirol-kliniken.at"},{"name":"Arno Amann, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.26266,"lon":11.39454}},{"facility":"Ordensklinikum Linz - BHS","status":"NOT_YET_RECRUITING","city":"Linz","state":"Upper Austria","zip":"4010","country":"Austria","contacts":[{"name":"Holger Rumpold, MD, Head","role":"CONTACT","phone":"+43-732-7677","phoneExt":"4230","email":"holger.rumpold@bhs.at"},{"name":"Holger Rumpold, MD, Head","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.30639,"lon":14.28611}},{"facility":"Kepler Universitätsklinikum Linz","status":"RECRUITING","city":"Linz","state":"Upper Austria","zip":"4020","country":"Austria","contacts":[{"name":"Gudrun Piringer, MD, MSc","role":"CONTACT","phone":"+435768082","email":"gudrun.piringer@kepleruniklinikum.at"},{"name":"Gudrun Piringer, MD, MSc","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.30639,"lon":14.28611}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Key-coded personal information from this study may also be used for future ((non-)commercial, (inter-)national) scientific research projects \\& statistics, provided the respective project is conducted in compliance with accepted standards of ethical principles; the responsible researcher(s)/statistician(s) has/have no legal means to de-identify any key-coded personal information.\n\nData will be shared with other collaborating academic groups/people \\& companies who work with the Sponsors, including but not limited to ECs, ABCSG (holder of clin. database) and will be used for study purposes mentioned in protocol \\& future scientific research projects, if agreed by the participant.\n\nAny data transfer will comply with respective applicable data law/regulations. The use of data must be defined in advance in a project description \\& SAP, approved by ABCSG Board/Committee and will be transferred acc. with resp. Data Transfer Agreement."}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-30"},"conditionBrowseModule":{"meshes":[{"id":"D012004","term":"Rectal Neoplasms"},{"id":"D009369","term":"Neoplasms"},{"id":"C536928","term":"Turcot syndrome"},{"id":"D000230","term":"Adenocarcinoma"}],"ancestors":[{"id":"D015179","term":"Colorectal Neoplasms"},{"id":"D007414","term":"Intestinal Neoplasms"},{"id":"D005770","term":"Gastrointestinal Neoplasms"},{"id":"D004067","term":"Digestive System Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D007410","term":"Intestinal Diseases"},{"id":"D012002","term":"Rectal Diseases"},{"id":"D002277","term":"Carcinoma"},{"id":"D009375","term":"Neoplasms, Glandular and Epithelial"},{"id":"D009370","term":"Neoplasms by Histologic Type"}]}},"hasResults":false},
{"protocolSection":{"identificationModule":{"nctId":"NCT07387263","orgStudyIdInfo":{"id":"4066"},"organization":{"fullName":"Unity Health Toronto","class":"OTHER"},"briefTitle":"Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing","officialTitle":"Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing"},"statusModule":{"statusVerifiedDate":"2026-06","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2026-04-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2027-12","type":"ESTIMATED"},"completionDateStruct":{"date":"2028-03","type":"ESTIMATED"},"studyFirstSubmitDate":"2025-12-17","studyFirstSubmitQcDate":"2026-01-27","studyFirstPostDateStruct":{"date":"2026-02-04","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-10-27","lastUpdatePostDateStruct":{"date":"2026-10-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Unity Health Toronto","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Genetic testing can alter therapy and surgical management for cancer patients and is therefore indicated as a first-line test for many newly diagnosed patients, including breast, ovarian, pancreatic, prostate and colon/GI patients. To reduce pressure on already constrained genetics clinics across Canada, some cancer centres are 'mainstreaming' genetic testing - whereby genetic testing is initiated and mediated by oncologists without traditional pre-test genetic counseling (GC) often using some form of paper-based patient pamphlets or videos. There is no standard, evidence-based approach to mainstreaming, leading to significant practice variation, a lack of coordinated care and ultimately, negative psychological impacts on patients. Digital solutions can address these gaps by providing a standardized, coordinated and patient-centered approach to deliver cancer genetic education. However, digital solutions for providing cancer genetics services are uncommon and clinical-effectiveness and service delivery outcomes have not been well-assessed. This study will test a digital mainstreaming platform called the Genetics Adviser for Mainstream care to assess its effectiveness in improving psychological outcomes and patient-centred care for mainstream cancer patients compared to standard of care.","detailedDescription":"Background: Germline genetic testing can alter therapy and surgical management for cancer patients. Yet, the rising demands for genetic testing and counseling has added pressure to already constrained genetic counseling (GC) service models that require extensive pre-test GC with a genetic counselor. Many cancer genetics centres are 'mainstreaming' genetic testing, replacing traditional pre-test GC, where genetic testing is initiated and mediated by oncologists, using clinician checklists, patient pamphlets, or videos. Most evidence on cancer genetics mainstream models to date derives from uncontrolled, non-randomized studies with limited outcomes. Electronic patient portals and digital decision tools have been shown to improve psychological outcomes.\n\nRationale: There is no standard, evidence-based approach to 'mainstreaming', leading to significant practice variation, a lack of coordinated care and ultimately, negative psychological impacts on patients. Digital solutions can address these gaps by providing a standardized, coordinated and patient-centred approach to deliver cancer genetic counseling. This study will address these gaps by testing the effectiveness of the Genetics Adviser for Mainstream Care (GA-Mainstream), building on our rigorously-evaluated digital health application called the Genetics Adviser.\n\nPrimary Objective: Assess the clinical effectiveness of the GA-Mainstream in improving psychological outcomes (e.g. test-specific distress), and patient-centred care (e.g. knowledge, and empowerment) for mainstream cancer patients compared to those receiving standard mainstream care.\n\nSecondary Objectives:\n\n* Measure the impact of the GA-Mainstream on patients' risk perceptions and intent to follow clinical recommendations (e.g. surveillance, treatment changes, or cascade testing).\n* Assess efficiencies in turnaround time to test result disclosure and time spent in genetic counselling sessions between groups.\n* Understand the experiences of patients and providers with the GA-Mainstream and the process of receiving genetic testing results through the platform.\n\nHypotheses\n\n* Patients who use the GA-Mainstream will report lower distress and higher knowledge and empowerment compared to standard-of-care mainstream patients.\n* Patients using the GA-Mainstream will have more accurate risk perceptions and higher intent to follow clinical recommendations.\n* Using the GA-Mainstream will reduce turnaround time and increase efficiency during genetic counselling sessions.\n\nMethods: This is a mixed-method, non-blinded randomized controlled superiority trial. The trial will evaluate whether the use of the GA-Mainstream reduces test-specific distress compared to standard mainstream genetic testing. As part of this trial, patients will receive germline genetic testing.\n\nStudy Population: Adult patients (aged \\>18 years) referred for mainstream cancer genetic testing related to ovarian, pancreatic, breast, prostate, or GI cancers.\n\nSample Size: Our primary outcome, test-specific distress measured using the MICRA, has an accepted minimal clinically important difference (MCID) of 2.5. Assuming this, 64 participants/arm (128 total) are estimated to be required to have 80% power at a 2-sided significance level of 0.05 to detect the MCID using a standard two-sample t-test.\n\nIntervention: Participants in the intervention arm will use the GA-Mainstream to support the delivery of their genetic test results, including collecting cancer medical history and family cancer history, pre- and post-result education. The GA-Mainstream will supplement mainstream standard of care.\n\nControl: Participants in the control arm will receive standard of care for mainstream patients as outlined by the clinic where the patient is being seen, which consists of a patient pamphlet, video, or clinician checklist for pre-test counseling and results disclosure by either a genetic counselor or oncologist with post-test counseling of select patients.\n\nPrimary Outcome: The primary outcome is test- specific distress, measured by the Multidimensional Impact of Cancer Risk Assessment (MICRA).\n\nSecondary Outcomes: Generalized distress, measured by the Hospital Anxiety and Depression Scale (HADS); Knowledge, measured by the KnowGene questionnaire; empowerment, measured by the Genomics Outcome Scale (GOS-6); Self-efficacy, measured by the Genetic self-efficacy scale; Quality of life measured by the 12-item Short Form Health Survey (SF-12); Satisfaction with genetics education and intended health behaviour change, assessed by team developed questions; Satisfaction with digital tool measured by the Digital Health Application Satisfaction Scale (DHASSP); digital health literacy measured by digital health care literacy scale; health literacy measured by the BRIEF Health Literacy Screening tool.\n\nTurnaround times will be measured by documenting time between blood draw, return of result and result disclosure by the clinician. Time saved will be measured by capturing time spent preparing for the session, during the session with the genetic counselor, and after the session across both arms. Frequency of platform use will also be documented and duration of platform use by recording platform access dates and time.\n\nQuantitative Analysis: Analysis will follow the intention-to-treat approach. Mean scores for test-specific distress will be compared using a t-test. Secondary outcomes of generalized distress, empowerment, and knowledge will also be analyzed using a t-test for hypothesis-generating purposes; therefore no multiplicity corrections will be applied. Mean wait times, total consult times and frequency and duration of use between arms will be analyzed descriptively and compared using a t-test. P-values will be set at 0.05 (two-tailed).\n\nQualitative Study: Following the trial, qualitative interviews will explore users' experiences with the GA-Mainstream. This will be used to explore participants' experiences, perceptions, and needs related to the use of the GA - Mainstream platform. A purposeful sample of study participants will be used. A mix of intervention arm participants (n=30) will be identified across cancer type, result type, and demographic characteristics to assess patient experience using the GA-Mainstream.\n\nQualitative Analysis: The qualitative analyses will draw on an interpretive description approach, using open coding and constant comparison to identify common and divergent themes. Interviews will consider participants' socio-demographic factors that may influence their informational and decisional needs, as well as how they engage with genetic information and participate in shared decision making. Two researchers will code transcripts independently; consensus on codes will be reached through discussion. Ongoing analysis will inform the development of progressive iterations of the interview guides.\n\nMixed-Methods Integration: The quantitative and qualitative data will be integrated to understand whether the tool is effective, including how and why it may influence outcomes such as distress, empowerment, and risk perception. Quantitative and qualitative findings will be narratively described and integrated using a convergent design matrix and joint displays, merged if appropriate."},"conditionsModule":{"conditions":["Cancer","Breast Cancer","Prostate Cancer","Colon Cancer","GI Cancers","Ovarian Cancer","Pancreatic Cancer"],"keywords":["Cancer Genetic Testing","Randomized Controlled Trial","Digital Tool","Mainstreaming","Genetic counseling","Cancer","Genetic testing","Service Delivery","Alternative service delivery model"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"HEALTH_SERVICES_RESEARCH","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":180,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Intervention arm - GA-Mainstream tool users","type":"EXPERIMENTAL","description":"Participants in the intervention arm will use the GA-Mainstream digital tool for cancer genetics education, providing cancer medical and family history, and to support the delivery of their genetic test results. This tool will be used to supplement usual care. Participants will continue to be supported by existing consultations with genetics professionals to discuss their results.","interventionNames":["Behavioral: Genetics Adviser for Mainstream Care (GA-Mainstream)","Behavioral: Mainstreaming Standard of Care"]},{"label":"Mainstreaming Standard of Care","type":"ACTIVE_COMPARATOR","description":"Participants in the control arm will receive mainstream care as outlined by the clinic where the patient is being seen, which consists of a patient pamphlet, video and/or a clinician checklist for pre-test counseling. Results will be disclosed by either a genetic counselor or oncologist with post-test counseling of select patients.","interventionNames":["Behavioral: Mainstreaming Standard of Care"]}],"interventions":[{"type":"BEHAVIORAL","name":"Genetics Adviser for Mainstream Care (GA-Mainstream)","description":"The Genetics Adviser for Mainstream Care will educate participants on cancer genetic testing after oncologist-initiated genetic testing. Participants may also receive their results on the GA-Mainstream.","armGroupLabels":["Intervention arm - GA-Mainstream tool users"],"otherNames":["GA-Mainstream"]},{"type":"BEHAVIORAL","name":"Mainstreaming Standard of Care","description":"After oncologist-initiated genetic testing, participants may not receive additional information prior to the receipt of their results or they may receive educational materials on cancer genetic testing. Results will be disclosed by either a genetic counselor or oncologist with post-test counseling of select patients.","armGroupLabels":["Intervention arm - GA-Mainstream tool users","Mainstreaming Standard of Care"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Test Specific Distress - Multi-Dimensional Impact of Cancer Risk Assessment (MICRA)","description":"The Multi-Dimensional Impact of Cancer Risk Assessment (MICRA) is a 25-item standardized, validated scale that measures the impact of result disclosure from genetic tests. There are three subscales: Distress (6 items), Uncertainty (9 items) and Positive Experiences (4 items). Total scores range from 0-125, with higher scores indicating worse outcome. Scores on the Distress subscale range from 0-30, with higher scores indicating worse outcome. Scores on the Uncertainty subscale range from 0-45, with higher scores indicating worse outcome. Scores on the Positive Experiences Subscale range from 0-20, with higher scores indicating worse outcomes. (PMID: 12433008)","timeFrame":"Assessed immediately after return of results via intervention (intervention arm only). Assessed at 2-weeks (primary timepoint) and 6 weeks post-return of results for everyone."}],"secondaryOutcomes":[{"measure":"Generalized Distress - Hospital Anxiety & Depression Scale (HADS)","description":"The Hospital Anxiety and Depression Scale (HADS) is a validated tool that assesses symptoms of anxiety and depression in medical and general populations. It consists of 14 items divided into two subscales: Anxiety (HADS-A) and Depression (HADS-D), each with 7 items scored on a 4-point Likert scale with scores ranging from 0-21 per subscale. The measure captures generalized psychological distress by evaluating non-somatic symptoms, making it suitable for use in clinical settings where physical illness may confound mood assessment. Higher scores indicate greater severity of anxiety and depressive symptoms, with established cut-offs for mild, moderate, and severe distress.","timeFrame":"Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); f) immediately post-return of results via intervention."},{"measure":"Knowledge - KnowGene","description":"Knowledge will be measured using KnowGene, a measure of knowledge about cancer genetic after cancer genetic counseling and multigene panel testing, an effective and established 16-item questionnaire. Response options include: agree, disagree, or 'don't know'. Either agree or disagree was considered a correct response, depending on the item, with responses being assigned a value of 0 or 1. Higher knowledge scores indicate a higher level of knowledge.","timeFrame":"Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); f) immediately post-return of results via intervention."},{"measure":"Empowerment - Genomics Outcome Scale (GOS-6)","description":"Measured by the Genomics Outcome Scale (GOS-6). The Genomics Outcome Scale (GOS) is a 6-item scale that measures empowerment and is a validated short-form of the 24-item Genetic Counselling Outcome Scale (GCOS-24). The 6-item GOS is shorter and more broadly applicable, such as in circumstances where a non-genetics provider has disclosed a result or when results are disclosed online. The GOS includes a 5-point Likert scale from strongly disagree (1 point) to strongly agree (5 points) for a possible score range of 6-30 points on this scale. (PMID: 30496830)","timeFrame":"Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); and f) immediately post-return of results via intervention."},{"measure":"Self-Efficacy - Genetic Self Efficacy Scale","description":"Measured by the Genetic Self Efficacy scale. This 5-item scale measures individuals' confidence in their ability to understand the genetic information provided. Participants will be asked to indicate their level of agreement or disagreement (7-point Likert scale from 1 = strongly disagree to 7 = strongly agree). Responses to the items will be summed, with higher scores indicating greater self-efficacy (range: 5-35).","timeFrame":"Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); and f) immediately post-return of results via intervention."},{"measure":"Quality of Life - Short Form Health Survey (SF-12)","description":"Quality of life will be measured using the validated Short Form Health Survey, 12-Item Version (SF-12). The 12-item scale assesses physical and mental health-related quality of life over a 4-week recall period. A Physical Component Summary (PCS) and Mental Component Summary (MCS) score will be calculated; scores are standardized to range from 0 to 100, with higher scores indicating better health-related quality of life.","timeFrame":"Assessed at: a) baseline; b) 2-weeks post-return of genetic test results (primary timepoint); and c) 6-weeks post-return of results."},{"measure":"Satisfaction with Genetics Education","description":"Satisfaction with genetics education will be assessed using items adapted from PMID: 28791521. Participants will rate clarity, helpfulness, and overall satisfaction with the education format using Likert-scale questions (e.g., 1 = very dissatisfied to 5 = very satisfied). Scores will be summed, with higher scores indicating greater satisfaction.","timeFrame":"Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); and f) immediately post-return of results via intervention."},{"measure":"Risk Perception - TRIpartite model of RISK perception (TRIRISK)","description":"Risk perception will be measured by the Tripartite Model of Risk Perception (TRIRISK), an 18 item scale assessing deliberative, affective, and experiential perceptions. These components are used to understand how people perceive and react to different health and other risks. Items are scored using 7-point Likert scales or percentage ratings. Each subscale has six items, and scores are averaged within each domain for a total score of 126. A high deliberative score means the person logically believes they are at high risk (e.g., based on probability). A high affective score means they feel emotionally concerned or worried about the risk. A high experiential score means they intuitively or personally feel vulnerable to the risk.","timeFrame":"Everyone assessed at: a) Baseline; b) 2-weeks post-return of genetic test results; and c) 6-weeks post-return of results. Intervention arm only: c) immediately post-return of results via the intervention."},{"measure":"Intended Health Behavioural Change Questions","description":"Guided by the health belief model of behaviour change, six questions were developed by the research team guided by the literature and experts. Questions will inquire about participants' intentions to: 1) obtain more information, 2) share genetic results with family, 3) communicate results with healthcare providers, 4) make lifestyle changes, 5) pursue screening, and 6) have preventative surgery.","timeFrame":"Assessed at a) baseline, b) 3-weeks after baseline; c) immediately after viewing results via the platform (intervention only), d) 2-weeks post-return of results, and e) 6-weeks post-return of results."},{"measure":"Satisfaction with Digital Tool - Digital Health Application Satisfaction Scale (DHASSP)","description":"Measured using the Digital Health Application Satisfaction Scale (DHASSP) to capture satisfaction with the digital tool, including usability, perceived usefulness, ease of navigation, and overall experience. Items are rated on a Likert scale (strongly disagree to strongly agree), with higher scores indicating greater satisfaction. The scale provides insight into user engagement and acceptability of the digital intervention.","timeFrame":"Administered to the intervention arm only: a) immediately post-first digital tool use (intervention), after baseline; b) immediately post-return of results via the intervention; and c) 2 weeks post-return of results."}],"otherOutcomes":[{"measure":"Qualitative interviews with a subset of participants and providers","description":"Interviews with patients will be used to gain further insights into the delivery and support of mainstreaming genetic services with the support of a digital intervention.","timeFrame":"1-6 months following return of results."},{"measure":"Health Literacy - BRIEF","description":"Health literacy will be assessed using the BRIEF Health Literacy Screening Tool, a 4-item measure designed to identify an individual's ability to understand and use health information. Each item is quantified using a 5-point scale (1-5) with higher scores indicating higher health literacy.","timeFrame":"Assessed at baseline."},{"measure":"Digital Health Literacy - Digital Health Care Literacy Scale","description":"Measured by the Digital Health Care Literacy Scale, a 3-Item measure of digital health literacy. Each item uses a 5-point Likert scale to answer each question with response options ranging from \"strongly agree\" (4 points) to \"strongly disagree\" (0 points). The sum of individual items is used to create the total score. Possible scores range from 0 to 12, with higher scores indicating higher digital health care literacy skills.","timeFrame":"Assessed at baseline."},{"measure":"Clinician time preparing for the session, counseling and post-session","description":"Measure of total time spent preparing for the genetic counselling session, time with the Genetic Counselor in the counselling session and time spent preparing letters and chart notes after the session. Collected for both the intervention and control arm.","timeFrame":"Collected at 2-weeks post-test result disclosure by the clinician."},{"measure":"Efficiency - Turnaround time","description":"To capture any efficiency caused by the intervention, turnaround time will be measured by collecting the date of blood draw, the date the genetic test report was returned, and the date of disclosure (by intervention vs. by clinician).","timeFrame":"Collected at 2-weeks post-test result disclosure by the clinician."},{"measure":"Frequency of platform use","description":"Measure of the number of times the digital platform was accessed by the participant. Intervention arm only.","timeFrame":"Collected at the end of participation in the study at 6-weeks post-test result disclosure (intervention arm only)."},{"measure":"Duration of platform session","description":"Measure of total time spent per participant using the digital platform. Intervention arm only.","timeFrame":"Collected at the end of participation in the study at 6-weeks post-test result disclosure (intervention arm only)."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Receiving mainstream cancer germline testing related to primary cancer condition (ie. ovarian, pancreas, breast, prostate, or GI cancers) initiated by an oncologist.\n* 18 years old or older.\n* Speak and read English\n\nExclusion Criteria:\n\n* Receiving genetic testing information via a referral to a genetics clinic\n* Do not speak or read English\n* Under 18 years of age\n* Determined to have diminished, marginal and or fluctuating decisional capacity\n* Lack access to internet or an electronic device","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Marc Clausen, MA","role":"CONTACT","phone":"416-864-6060","phoneExt":"77397","email":"marc.clausen@unityhealth.to"},{"name":"Daniel Assamad, MHSc","role":"CONTACT","email":"d.abdassamad@mail.utoronto.ca"}],"overallOfficials":[{"name":"Yvonne Bombard, PhD","affiliation":"St. Michael's Hospital and University of Toronto","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Sunnybrook Hospital","status":"RECRUITING","city":"Toronto","state":"Ontario","zip":"M4N 3M5","country":"Canada","contacts":[{"name":"Marc Clausen, MA","role":"CONTACT","phone":"416-864-6060","phoneExt":"77397","email":"Marc.Clausen@unityhealth.to"},{"name":"Andrea Eisen, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Mount Sinai Hospital","status":"RECRUITING","city":"Toronto","state":"Ontario","zip":"M5G 1X5","country":"Canada","contacts":[{"name":"Marc Clausen, MA","role":"CONTACT","phone":"416-864-6060","phoneExt":"77397","email":"Marc.Clausen@unityhealth.to"},{"name":"Christine Elser, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":43.70643,"lon":-79.39864}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Data will be made available to researchers who are interested in / conducting similar research in this field. De-identified participant data, the study protocol, and the statistical analysis plan will be available upon reasonable request to the corresponding author, subject to institutional and ethical approvals, to achieve the aims in methodologically sound and approved proposals.","infoTypes":["STUDY_PROTOCOL","SAP","ICF"],"timeFrame":"Following study data publication, and for five years thereafter, de-identified participant data, the study protocol, and statistical analysis plan will be available upon reasonable request to the corresponding author, subject to institutional and ethical approvals, to achieve aims in methodologically sound and approved proposals.","accessCriteria":"Data will be made available to researchers who are interested in / conducting similar research in this field. This data will be available upon reasonable request to the corresponding author, subject to institutional and ethical approvals, to achieve the aims in approved proposals.\n\nTo gain access, data requestors will need to sign a data access agreement."}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-30"},"conditionBrowseModule":{"meshes":[{"id":"D009369","term":"Neoplasms"},{"id":"D001943","term":"Breast Neoplasms"},{"id":"D011471","term":"Prostatic Neoplasms"},{"id":"D003110","term":"Colonic Neoplasms"},{"id":"D010051","term":"Ovarian Neoplasms"},{"id":"D010190","term":"Pancreatic Neoplasms"}],"ancestors":[{"id":"D009371","term":"Neoplasms by Site"},{"id":"D001941","term":"Breast Diseases"},{"id":"D012871","term":"Skin Diseases"},{"id":"D017437","term":"Skin and Connective Tissue Diseases"},{"id":"D005834","term":"Genital Neoplasms, Male"},{"id":"D014565","term":"Urogenital Neoplasms"},{"id":"D005832","term":"Genital Diseases, Male"},{"id":"D000091662","term":"Genital Diseases"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D011469","term":"Prostatic Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D015179","term":"Colorectal Neoplasms"},{"id":"D007414","term":"Intestinal Neoplasms"},{"id":"D005770","term":"Gastrointestinal Neoplasms"},{"id":"D004067","term":"Digestive System Neoplasms"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D003108","term":"Colonic Diseases"},{"id":"D007410","term":"Intestinal Diseases"},{"id":"D004701","term":"Endocrine Gland Neoplasms"},{"id":"D010049","term":"Ovarian Diseases"},{"id":"D000291","term":"Adnexal Diseases"},{"id":"D005831","term":"Genital Diseases, Female"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D005833","term":"Genital Neoplasms, Female"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D006058","term":"Gonadal Disorders"},{"id":"D010182","term":"Pancreatic Diseases"}]}},"hasResults":false},
{"protocolSection":{"identificationModule":{"nctId":"NCT05319314","orgStudyIdInfo":{"id":"LYL273-101"},"organization":{"fullName":"Lyell Immunopharma, Inc.","class":"INDUSTRY"},"briefTitle":"LYL273 for Patients With Relapsed or Refractory mCRC","officialTitle":"A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of LYL273 in Patients With Relapsed or Refractory Metastatic Colorectal Cancer","acronym":"CARABiNER"},"statusModule":{"statusVerifiedDate":"2026-06","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-08-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2028-06","type":"ESTIMATED"},"completionDateStruct":{"date":"2032-06","type":"ESTIMATED"},"studyFirstSubmitDate":"2022-03-23","studyFirstSubmitQcDate":"2022-03-31","studyFirstPostDateStruct":{"date":"2022-04-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-10-28","lastUpdatePostDateStruct":{"date":"2026-10-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Lyell Immunopharma, Inc.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a Phase 1/2 open-label, multicenter study evaluating the safety and efficacy of LYL273 in participants with relapsed or refractory metastatic colorectal cancer.","detailedDescription":"LYL273-101 (CARABiNER) is a Phase 1/2 open label, multicenter study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of LYL273, a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, in participants with relapsed or refractory metastatic colorectal cancer (mCRC).\n\nThe study may enroll multiple dose expansion cohorts at the Sponsor's discretion to further characterize the safety, feasibility, and preliminary antitumor activity of LYL273 under defined treatment conditions including those defined below.\n\n1. Cohorts to explore alternative mCRC patient populations\n\n   Expansion cohorts may enroll a broader array of the mCRC population as listed below:\n   * Earlier mCRC: Patients who have had a maximum of 1 prior line of systemic therapy\n2. Cohorts to explore LYL273 in combination with other anti-cancer therapies Expansion cohorts may explore LYL273 in combination with consolidative radiotherapy.\n\nUp to 18 participants will be enrolled into each expansion cohort with up to approximately 95 patients enrolled in the Phase 1 portion of the study.\n\nThe Phase 2 portion of the study will expand enrollment at the recommended Phase 2 dose of approximately 60 additional patients.\n\nLYL273 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered once, 3 days before LYL273 infusion.\n\nIndividual participants will remain in the active post-treatment follow-up (PTFU) period for up to 5 years. Participants will continue in long-term follow-up (LTFU) for 15 years from LYL273 treatment in a separate protocol."},"conditionsModule":{"conditions":["Colorectal Cancer"],"keywords":["relapsed metastatic colorectal cancer","refractory metastatic colorectal cancer","chimeric antigen receptors (CAR)","colorectal cancer","metastatic colorectal cancer","mCRC","CAR T-cell","guanylyl cyclase C","GCC","colorectal neoplasms","autologous T cells"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1","PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SEQUENTIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":155,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"LYL273","type":"EXPERIMENTAL","description":"Single infusion of LYL273 at the dose assigned to an individual participant.\n\nAll participants will receive the same investigational therapy with the dose administered dependent upon the dose level they are assigned to in a sequential manner.","interventionNames":["Drug: LYL273"]}],"interventions":[{"type":"DRUG","name":"LYL273","description":"Single infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)","armGroupLabels":["LYL273"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Phase 1: Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs) during 3+3 dose escalation study","timeFrame":"Infusion (Day 0) to Day 28"},{"measure":"Phase 1: Maximum tolerable dose (MTD) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study","timeFrame":"Infusion (Day 0) to Day 28"},{"measure":"Phase 1: Recommended Phase 2 dose (RP2D) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study","timeFrame":"Infusion (Day 0) to Day 28"},{"measure":"Phase 2: Estimate the efficacy of LYL273, as measured by overall response rate (ORR) based on Independent Review Committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 criteria","timeFrame":"Baseline to Month 18"}],"secondaryOutcomes":[{"measure":"Phase 1 and 2: Evaluate the efficacy of LYL273","description":"ORR based on investigator assessment per RECIST Version 1.1 criteria","timeFrame":"Infusion (Day 0) until the date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria, assessed up to 18 months"},{"measure":"Phase 1 and 2: Evaluate the efficacy of LYL273","description":"Duration of response (DOR) based on Investigator assessment per RECIST Version 1.1 criteria.","timeFrame":"Date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria until the date of disease progression or recurrence or date of death whichever comes first"},{"measure":"Phase 1 and 2: Evaluate the efficacy of LYL273","description":"Time to response based on Investigator assessment per RECIST Version 1.1 criteria.","timeFrame":"Infusion (Day 0) until the date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria, assessed up to 18 months"},{"measure":"Phase 2: Evaluate the efficacy of LYL273","description":"Duration of response based on IRC assessment per RECIST Version 1.1 criteria","timeFrame":"Date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria until the date of disease progression or recurrence or date of death whichever comes first"},{"measure":"Phase 2: Evaluate the efficacy of LYL273","description":"Time to response based on IRC assessment per RECIST Version 1.1 criteria","timeFrame":"Infusion (Day 0) until the date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria, assessed up to 18 months"},{"measure":"Phase 1 and 2: Evaluate the efficacy of LYL273","description":"Progression free survival (PFS) based on Investigator assessment per RECIST Version 1.1 criteria","timeFrame":"Infusion (Day 0) until the date of first documented progression/recurrence or date of death from any cause, whichever comes first"},{"measure":"Phase 1 and 2: Overall Survival (OS)","description":"Overall survival (OS)","timeFrame":"Infusion (Day 0) until date of death from any cause"},{"measure":"Phase 2: Incidence and severity of adverse events","timeFrame":"Infusion (Day 0) to 3 months"},{"measure":"Phase 1 and 2: Cellular Kinetics","description":"Maximum concentration (Cmax), time to peak cell expansion (Tmax), area under the concentration curve from time 0 to Day 28 (AUC0-28), and cellular persistence (time of last measurable concentration \\[Tlast\\]) for the GCC CAR T cells","timeFrame":"Infusion (Day 0) up to 18 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adults \\> 18 years old\n* Clinical and histopathological diagnosis of relapsed or refractory metastatic colorectal cancer\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)\n* No surgical options with curative intent\n* Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment must have been discontinued for disease progression or intolerance to therapy\n* Have at least one extracranial measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 standard\n\nExclusion Criteria:\n\n* Participants with tumor lesion(s) in a location that may cause perforation of an organ or structure (such as the digestive tract, urinary bladder, or blood vessel) with LYL273 therapy\n* Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT)\n* History of or active viral infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement in the 2-year period leading up to the study enrollment\n* No active infectious diseases or comorbid conditions that would interfere with safety or data quality\n* Pregnant or breast-feeding women\n\nOther protocol defined Inclusion/Exclusion criteria may apply","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"City of Hope Comprehensive Cancer Center","status":"RECRUITING","city":"Duarte","state":"California","zip":"91010","country":"United States","contacts":[{"name":"Jessica Mathias","role":"CONTACT","phone":"626-218-4088","email":"jmathias@coh.org"},{"name":"Kimberly Le","role":"CONTACT","phone":"626-218-2997","email":"kimle@coh.org"}],"geoPoint":{"lat":34.13945,"lon":-117.97729}},{"facility":"University of California San Francisco Medical Center","status":"RECRUITING","city":"San Francisco","state":"California","zip":"94143","country":"United States","contacts":[{"name":"UCSF Team","role":"CONTACT","phone":"415-353-2421","email":"HDFCCC.CIP@ucsf.edu"}],"geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"University of Colorado Hospital - Anschutz Cancer Pavilion","status":"RECRUITING","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","contacts":[{"name":"Meredith Waring","role":"CONTACT","phone":"303-724-9840","email":"meredith.waring@cuanschutz.edu"},{"name":"Alexander Pung","role":"CONTACT","phone":"303-724-9632","email":"alexander.pung@cuanschutz.edu"}],"geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Dana-Farber Cancer Institute","status":"RECRUITING","city":"Boston","state":"Massachusetts","zip":"02215-5418","country":"United States","contacts":[{"name":"Jamie Dela Cruz","role":"CONTACT","phone":"857-215-2833","email":"jamiep_delacruz@dfci.harvard.edu"}],"geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"SCRI Oncology Partners and Tristar Centennial Hospital","status":"RECRUITING","city":"Nashville","state":"Tennessee","zip":"37203","country":"United States","contacts":[{"name":"AskSarah Help Line","role":"CONTACT","phone":"844-482-4812","email":"scri.ddureferrals@scri.com"}],"geoPoint":{"lat":36.16589,"lon":-86.78444}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-30"},"conditionBrowseModule":{"meshes":[{"id":"D015179","term":"Colorectal Neoplasms"}],"ancestors":[{"id":"D007414","term":"Intestinal Neoplasms"},{"id":"D005770","term":"Gastrointestinal Neoplasms"},{"id":"D004067","term":"Digestive System Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D003108","term":"Colonic Diseases"},{"id":"D007410","term":"Intestinal Diseases"},{"id":"D012002","term":"Rectal Diseases"}]}},"hasResults":false}
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