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Molecular Profiling of Advanced Biliary Tract Cancers (COMPASS-B-MUHC)

Primary Purpose

Biliary Tract Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tumour and germline molecular profiling
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Biliary Tract Cancer focused on measuring Biliary tract cancer, Cholangiocarcinoma, Molecular Profiling, Whole Genome Sequencing, Whole Transcriptome Sequencing

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 BTC.
  • Patient must have a tumour that is amenable to a core needle biopsy.
  • 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 to safely undergo a tumour biopsy as judged by the investigator.
  • Eastern Cooperative Group (ECOG) performance status ≤ 1.
  • Life expectancy of greater than 90 days.
  • Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
  • Patients must undergo systemic treatment with gemcitabine-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 tumour biopsy.
  • Patients who have had any prior chemotherapy or other anti-cancer agent in the advanced stage setting.
  • Patients who are currently on anti-cancer treatment.
  • Patients with known brain metastases.
  • Uncontrolled concurrent illness that would limit compliance with study requirements.
  • Any other condition that would contraindicate the patient's participation due to safety concerns or compliance with clinical study procedures.

Sites / Locations

  • McGill University Health CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Individuals with advanced biliary tract cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with tumour whole genome sequencing returned within 8 weeks
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.

Secondary Outcome Measures

Disease control rate
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
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
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
based on whole genome sequencing or RNA sequencing analyses.
Number of patients who received a targeted therapy (after first-line treatment)
based on the identification of an actionable mutation by whole genome sequencing or RNA sequencing.

Full Information

First Posted
February 24, 2020
Last Updated
November 2, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Cancer Research Society
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1. Study Identification

Unique Protocol Identification Number
NCT04318834
Brief Title
Molecular Profiling of Advanced Biliary Tract Cancers
Acronym
COMPASS-B-MUHC
Official Title
Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers for Better Treatment Selection: a McGill University Health Centre Study (COMPASS-B-MUHC)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Cancer Research Society

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
Biliary tract cancer (BTC) accounts for <1% of all cancers, but remains a highly fatal malignancy. Surgical resection is the only hope for cure, but most patients present with advanced disease when curative-intent surgery is not possible. The therapeutic options for patients with advanced disease are limited, primarily to chemotherapeutic regimens, which are based on empiric evidence without the use of biomarkers. These current treatment strategies have been largely ineffective in controlling the disease, resulting in poor survival outcomes of less than 1 year. An understanding of the molecular characteristics of biliary tract cancer may enable stratification of patients into therapies that target specific molecular alterations with greater efficacies and improved clinical outcomes. This study aims to investigate the feasibility and clinical utility of prospective molecular profiling of advanced biliary tract cancer. The primary endpoint of this study is to demonstrate the feasibility of returning whole genome sequencing results within 8 weeks of tumour biopsy for second-line treatment consideration (n=30 patients). In parallel, tumour whole transcriptome sequencing will be performed to identify actionable molecular alterations (e.g., fusion transcripts). Once the primary endpoint is met, the study will be expanded. Current funding allows expansion to 40 patients in total.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
Keywords
Biliary tract cancer, Cholangiocarcinoma, Molecular Profiling, Whole Genome Sequencing, Whole Transcriptome Sequencing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individuals with advanced biliary tract cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tumour and germline molecular profiling
Intervention Description
Tumour whole genome sequencing, germline whole genome sequencing, tumour whole transcriptome sequencing
Primary Outcome Measure Information:
Title
Number of participants with tumour whole genome sequencing returned within 8 weeks
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease control rate
Description
Number of patients that achieve stability of disease (cancer) by imaging (RECIST criteria) with first-line standard chemotherapy, consisting of gemcitabine backbone.
Time Frame
4 years
Title
Progression-free survival rate
Description
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.
Time Frame
4 years
Title
Overall survival rate
Description
Overall survival (OS) defined as the interval between the date of registration and the date of death of patients treated with 1st line chemotherapy.
Time Frame
4 years
Title
Number of patients in whom at least 1 actionable mutation is identified
Description
based on whole genome sequencing or RNA sequencing analyses.
Time Frame
4 years
Title
Number of patients who received a targeted therapy (after first-line treatment)
Description
based on the identification of an actionable mutation by whole genome sequencing or RNA sequencing.
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 BTC. Patient must have a tumour that is amenable to a core needle biopsy. 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 to safely undergo a tumour biopsy as judged by the investigator. Eastern Cooperative Group (ECOG) performance status ≤ 1. Life expectancy of greater than 90 days. Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function. Patients must undergo systemic treatment with gemcitabine-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 tumour biopsy. Patients who have had any prior chemotherapy or other anti-cancer agent in the advanced stage setting. Patients who are currently on anti-cancer treatment. Patients with known brain metastases. Uncontrolled concurrent illness that would limit compliance with study requirements. Any other condition that would contraindicate the patient's participation due to safety concerns or compliance with clinical study procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Zogopoulos, MD, PhD
Phone
514-934-1934
Ext
76333
Email
george.zogopoulos@mcgill.ca
Facility Information:
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Gardner
Phone
514-934-1934
Ext
76333
Email
jennifer.gardner@affiliate.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Adeline Cuggia, MSc
Phone
514-934-1934
Ext
76333
Email
cancer.pancreas@mcgill.ca
First Name & Middle Initial & Last Name & Degree
George Zogopoulos, MD, PhD
First Name & Middle Initial & Last Name & Degree
Yifan Wang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Molecular Profiling of Advanced Biliary Tract Cancers

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