| Title |
Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers for Better Treatment Selection: a McGill University Health Centre Study |
| Protocole ID |
COMPASS-B-MUHC |
| ClinicalTrials.gov ID |
NCT04318834 |
| Cancer Type(s) |
Hepatic Ducts |
| Phase |
Other |
| Stage |
|
| Study Type |
Genetic |
| Drug |
|
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| City |
|
| Principal Investigator |
Dr. George Zogopoulos
|
| Coordinator |
Crystal Haigh
514-934-1934 poste 76333
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility 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.
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| |
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Groupe d'étude en oncologie du Québec