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Molecular Profiling

Molecular Profiling for Biliary Tract Cancer (COMPASS-B-MUHC Trial)

N/A

Recruiting

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

COMPASS-B-MUHC Trial Summary

This trial is investigating the feasibility of returning whole genome sequencing results within 8 weeks of a biliary tract cancer tumor biopsy, in order to identify actionable molecular alterations that may improve clinical outcomes.

Who is the study for?

This trial is for adults with advanced biliary tract cancer that can't be removed by surgery. They must have a measurable tumor, understand and sign consent, have an ECOG status ≤1 (which means they are able to walk and capable of all self-care), expect to live more than 90 days, and have normal organ/marrow function. They should've had gemcitabine-based treatment first without success.Check my eligibility

What is being tested?

The study tests the process of molecular profiling on tumors from patients with advanced biliary tract cancer. It aims to return whole genome sequencing results within 8 weeks after biopsy for second-line treatment consideration. The goal is to find specific molecular changes in the cancer that could lead to more effective treatments.See study design

What are the potential side effects?

Since this trial focuses on molecular profiling rather than drug intervention, typical medication side effects aren't applicable here. However, there may be risks associated with the biopsy procedure used for obtaining tissue samples such as pain, bleeding or infection.

COMPASS-B-MUHC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving or will receive gemcitabine as my first treatment.

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I have a tumor that can be measured and another that can be biopsied.

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My tumor can be biopsied with a needle.

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My bile duct cancer cannot be removed by surgery or has spread.

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I can carry out all my self-care but not work activities.

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My organs and bone marrow are functioning normally.

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I am considered fit for a tumor biopsy.

COMPASS-B-MUHC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Disease control rate

Number of patients in whom at least 1 actionable mutation is identified

Therapeutic procedure

+2 more

COMPASS-B-MUHC Trial Design

1Treatment groups

Experimental Treatment

Group I: Individuals with advanced biliary tract cancerExperimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

442 Previous Clinical Trials

159,134 Total Patients Enrolled

Cancer Research SocietyUNKNOWN

1 Previous Clinical Trials

Media Library

Tumour and germline molecular profiling (Molecular Profiling) Clinical Trial Eligibility Overview. Trial Name: NCT04318834 — N/A

Biliary Tract Cancer Research Study Groups: Individuals with advanced biliary tract cancer

Biliary Tract Cancer Clinical Trial 2023: Tumour and germline molecular profiling Highlights & Side Effects. Trial Name: NCT04318834 — N/A

Tumour and germline molecular profiling (Molecular Profiling) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04318834 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants for this research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov reports that this research is actively recruiting participants, having been first published on April 1st 2020 and last updated November 2nd 2022. A total of 40 individuals must be enrolled from a single centre for the trial to proceed."

Answered by AI

Is enrollment for this experiment currently available?

"According to clinicaltrials.gov, this experiment is in the process of seeking participants; it was initially made available on April 1st 2020 and recently amended on November 2nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Molecular Profiling of Advanced Biliary Tract Cancers

George Zogopoulos 2020. "Molecular Profiling of Advanced Biliary Tract Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04318834.