Biliary Tract CancerCOMPASS-B-MUHCNCT04318834
Molecular Profiling of Advanced Biliary Tract Cancers
A study testing Tumour and germline molecular profiling in people with Biliary Tract Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Tumour and germline molecular profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2020to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Jennifer Gardner, 514-934-1934 ext. 76333, jennifer.gardner@affiliate.mcgill.ca
Adeline Cuggia, MSc, 514-934-1934 ext. 76333, cancer.pancreas@mcgill.ca
About this study
Official title: Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers for Better Treatment Selection: a McGill University Health Centre Study (COMPASS-B-MUHC)
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.
- Conditions
- Biliary Tract Cancer
- Being tested
- Tumour and germline molecular profiling
- Keywords
- Biliary tract cancer, Cholangiocarcinoma, Molecular Profiling, Whole Genome Sequencing, Whole Transcriptome Sequencing
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumour and germline molecular profilingOther
Tumour whole genome sequencing, germline whole genome sequencing, tumour whole transcriptome sequencing
| Study group | Role | What they receive |
|---|---|---|
| Individuals with advanced biliary tract cancer | Experimental | 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. Receives: Other: Tumour and germline molecular profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
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.
Measured: 4 years
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.
Measured: 4 years
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.
Measured: 4 years
Number of patients in whom at least 1 actionable mutation is identified
based on whole genome sequencing or RNA sequencing analyses.
Measured: 4 years
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Apr 2020
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research Society
- Responsible party
- Principal investigator, George Zogopoulos, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318834
- Sponsor's protocol ID
- 2020-6112
- Acronym
- COMPASS-B-MUHC
- Status last verified
- Apr 2024
- First submitted
- 24 Feb 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers for Better Treatment Selection: a McGill University Health Centre Study (COMPASS-B-MUHC)
- ClinicalTrials.gov ID
- NCT04318834
- Acronym / sponsor ID
- COMPASS-B-MUHC / 2020-6112
- Conditions
- Biliary Tract Cancer
- Keywords
- Biliary tract cancer, Cholangiocarcinoma, Molecular Profiling, Whole Genome Sequencing, Whole Transcriptome Sequencing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Cancer Research Society
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with advanced biliary tract cancer | Experimental | Other: Tumour and germline molecular profilingFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumour and germline molecular profilingTumour whole genome sequencing, germline whole genome sequencing, tumour whole transcriptome sequencing | Other | Individuals with advanced biliary tract cancer |
Primary outcome
Number of participants with tumour whole genome sequencing returned within 8 weeks
Time frame: 2 years
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.
5 secondary outcomes
Disease control rate
Time frame: 4 years
Progression-free survival rate
Time frame: 4 years
Overall survival rate
Time frame: 4 years
Number of patients in whom at least 1 actionable mutation is identified
Time frame: 4 years
Number of patients who received a targeted therapy (after first-line treatment)
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Cancer
Active, not recruitingPhase 2/3
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Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumour and germline molecular profiling in people with Biliary Tract Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Zogopoulos, MD, PhD (514-934-1934 ext. 76333, george.zogopoulos@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with tumour whole genome sequencing returned within 8 weeks (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.