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Molecular 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Withdrawn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
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Biliary Tract Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 7, 2017
    Last Updated
    March 30, 2021
    Sponsor
    University Health Network, Toronto
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    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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