Status:
RECRUITING
Molecular Profiling of Advanced Biliary Tract Cancers
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Cancer Research Society
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04318834
Start Date
April 1 2020
End Date
January 1 2025
Last Update
April 17 2024
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1