- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03419247
Molecular Profiling of Advanced Biliary Tract Cancers
March 30, 2021 updated by: University Health Network, Toronto
Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers (BTC) for Better Treatment Selection: A Prospective Study (COMPASS B)
This is a study where fresh tumor tissue and blood samples will be collected from patients with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine or fluorouracil (5-FU) regimens to see how useful it is to look for changes and characteristics in genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour to find characteristics that may be useful in choosing treatments for patients in the future.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Changes (mutations) in genes have been shown to be an important characteristic in cancers.
Looking at differences in genes in patients with unresectable or metastatic biliary tract cancer and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have a histological or radiological diagnosis of inoperable or metastatic biliary tract cancer (BTC).
- Patient must have a tumor lesion that is amenable to a core needle biopsy as judged by a staff radiologist.
- Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
- Patients must be fit enough to safely undergo a tumor biopsy as judged by the investigator.
- Eastern Cooperative Group (ECOG) performance status ≤ 1 (Karnofsky ≥60%).
- Life expectancy of greater than 90 days, as judged by the investigator.
- Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
- Patients must undergo systemic treatment with gemcitabine or 5-FU based regimens as first line standard systemic palliative treatment with or without other investigational agents within a clinical trial.
- Ability to understand and willing to sign a written informed consent document.
Exclusion Criteria:
- Patients with one or more contraindications to tumor biopsy.
- Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the advanced setting.
- Patients who are currently on anti-cancer treatment including chemotherapy.
- Patients with known brain metastases are excluded from participation in this clinical study.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tumor tissue and blood sample collection
|
A type of surgical procedure that will use a thin needle to remove a sample of tumor tissue.
Blood will be taken by a needle from a vein.
A sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.
Time Frame: 8 Weeks
|
8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease control rate
Time Frame: 4 years
|
4 years
|
Progression-free survival rate
Time Frame: 4 years
|
4 years
|
Overall survival rate
Time Frame: 4 years
|
4 years
|
Genomic predictors of response to chemotherapy identified
Time Frame: 4 years
|
4 years
|
Germline mutations of hereditary risk factors
Time Frame: 4 years
|
4 years
|
Potential predictive biomarkers of response to treatment such as BRCA, PALB2 and ATM mutations.
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer J Knox, M.D., Princess Margaret Cancer Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 1, 2020
Primary Completion (ANTICIPATED)
January 2, 2022
Study Completion (ANTICIPATED)
January 2, 2023
Study Registration Dates
First Submitted
December 7, 2017
First Submitted That Met QC Criteria
January 25, 2018
First Posted (ACTUAL)
February 1, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COMPASS-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Biliary Tract Cancer
-
Sun Yat-sen UniversityJiangsu Hengrui Pharmaceutical Co., Ltd.Not yet recruitingMetastatic Biliary Tract Cancer | Locally Advanced Biliary Tract CancerChina
-
Gyeongsang National University HospitalSamsung Medical Center; Dong-A University; Chung-Ang UniversityTerminatedMetastatic Biliary Tract Cancer | Locally Advanced Biliary Tract CancerKorea, Republic of
-
Hospital de Cancer de Barretos - Fundacao Pio XIIUnknown
-
Fudan UniversityRecruitingAdvanced Biliary Tract CancerChina
-
Innovent Biologics (Suzhou) Co. Ltd.RecruitingAdvanced Biliary Tract CancerChina
-
Tianjin Medical University Cancer Institute and...RecruitingResectable Biliary Tract CancerChina
-
University of Kansas Medical CenterRecruitingAdvanced Biliary Tract CancerUnited States
-
Peking Union Medical College HospitalShanghai Junshi Bioscience Co., Ltd.RecruitingAdvanced Biliary Tract CancerChina
-
Georgetown UniversityIpsenRecruitingAdvanced Biliary Tract CancerUnited States
-
Seoul National University HospitalBeiGeneActive, not recruitingAdvanced Biliary Tract CancerKorea, Republic of
Clinical Trials on Fresh tumor tissue biopsy
-
University of ArkansasActive, not recruitingHead and Neck Cancer | Lung CancerUnited States
-
Gustave Roussy, Cancer Campus, Grand ParisRecruitingSarcoma | Brain Tumor | Neuroblastoma | Kidney TumorFrance
-
St. Jude Children's Research HospitalCompletedTumor, SolidUnited States
-
Stanford UniversityNational Institutes of Health (NIH)RecruitingStomach Cancer | Esophageal Cancer | Gastrointestinal Stromal Tumor (GIST) | Gastric (Stomach) Cancer | Gastro-Esophageal(GE) Junction CancerUnited States
-
University Health Network, TorontoCompleted
-
Jianzhen Shan, MDRecruitingGastric Cancer | Pancreatic CancerChina
-
Tata Memorial HospitalRecruitingBreast Cancer FemaleIndia
-
PfizerTerminatedDisease ProgressionUnited States, Belgium, France, Argentina, United Kingdom
-
Assistance Publique Hopitaux De MarseilleRecruiting
-
National Cancer Institute (NCI)Terminated