Back to resultsMolecular Profiling of Advanced Biliary Tract Cancers
Primary Purpose
Biliary Tract Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fresh tumor tissue biopsy
Blood draw
Archival tumor tissue collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Biliary Tract Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tumor tissue and blood sample collection
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.
Secondary Outcome Measures
Disease control rate
Progression-free survival rate
Overall survival rate
Genomic predictors of response to chemotherapy identified
Germline mutations of hereditary risk factors
Potential predictive biomarkers of response to treatment such as BRCA, PALB2 and ATM mutations.
Full Information
NCT ID
NCT03419247
First Posted
December 7, 2017
Last Updated
March 30, 2021
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03419247
Brief Title
Molecular Profiling of Advanced Biliary Tract Cancers
Official Title
Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers (BTC) for Better Treatment Selection: A Prospective Study (COMPASS B)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not activated
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 2, 2022 (Anticipated)
Study Completion Date
January 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tumor tissue and blood sample collection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Fresh tumor tissue biopsy
Intervention Description
A type of surgical procedure that will use a thin needle to remove a sample of tumor tissue.
Intervention Type
Procedure
Intervention Name(s)
Blood draw
Intervention Description
Blood will be taken by a needle from a vein.
Intervention Type
Procedure
Intervention Name(s)
Archival tumor tissue collection
Intervention Description
A sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected.
Primary Outcome Measure Information:
Title
Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Disease control rate
Time Frame
4 years
Title
Progression-free survival rate
Time Frame
4 years
Title
Overall survival rate
Time Frame
4 years
Title
Genomic predictors of response to chemotherapy identified
Time Frame
4 years
Title
Germline mutations of hereditary risk factors
Time Frame
4 years
Title
Potential predictive biomarkers of response to treatment such as BRCA, PALB2 and ATM mutations.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer J Knox, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Molecular Profiling of Advanced Biliary Tract Cancers
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