Molecular Profiling of Advanced Biliary Tract Cancers (COMPASS-B-MUHC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04318834|
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : February 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Cancer||Other: Tumour and germline molecular profiling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers for Better Treatment Selection: a McGill University Health Centre Study (COMPASS-B-MUHC)|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2024|
Experimental: Individuals with advanced biliary tract cancer
Following a tumour biopsy for molecular profiling, chemo-naive patients with advanced biliary tract cancer will receive first-line gemcitabine-based chemotherapy or an investigational drug on a participating clinical trial.
Other: Tumour and germline molecular profiling
Tumour whole genome sequencing, germline whole genome sequencing, tumour whole transcriptome sequencing
- Number of participants with tumour whole genome sequencing returned within 8 weeks [ Time Frame: 2 years ]We have estimated that 30 patients will be required to reach the primary end point, which will be met if we demonstrate that tumor whole genome sequencing data is available at 8 weeks from the tumour biopsy for 80% of patients.
- Disease control rate [ Time Frame: 4 years ]Number of patients that achieve stability of disease (cancer) by imaging (RECIST criteria) with first-line standard chemotherapy, consisting of gemcitabine backbone.
- Progression-free survival rate [ Time Frame: 4 years ]Progression free survival (PFS) defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with 1st line chemotherapy.
- Overall survival rate [ Time Frame: 4 years ]Overall survival (OS) defined as the interval between the date of registration and the date of death of patients treated with 1st line chemotherapy.
- Number of patients in whom at least 1 actionable mutation is identified [ Time Frame: 4 years ]based on whole genome sequencing or RNA sequencing analyses.
- Number of patients who received a targeted therapy (after first-line treatment) [ Time Frame: 4 years ]based on the identification of an actionable mutation by whole genome sequencing or RNA sequencing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318834
|Contact: George Zogopoulos, MD, PhD||514-934-1934 ext firstname.lastname@example.org|
|McGill University Health Centre||Recruiting|
|Montréal, Quebec, Canada, H4A 3J1|
|Contact: Crystal Haigh, BA 514-934-1934 ext 76333 email@example.com|
|Contact: Adeline Cuggia, MSc 514-934-1934 ext 76333 firstname.lastname@example.org|
|Principal Investigator: George Zogopoulos, MD, PhD|
|Sub-Investigator: Yifan Wang, MD|