Clinical trial NCT03419247: Molecular Profiling of Advanced Biliary Tract Cancers
Official title: Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers (BTC) for Better Treatment Selection: A Prospective Study (COMPASS B)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Biliary Tract Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study where fresh tumor tissue and blood samples will be collected from patients with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine or fluorouracil (5-FU) regimens to see how useful it is to look for changes and characteristics in genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour to find characteristics that may be useful in choosing treatments for patients in the future.

Detailed description: Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with unresectable or metastatic biliary tract cancer and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.

Eligibility criteria: Inclusion Criteria:

* Patients must have a histological or radiological diagnosis of inoperable or metastatic biliary tract cancer (BTC).
* Patient must have a tumor lesion that is amenable to a core needle biopsy as judged by a staff radiologist.
* 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 enough to safely undergo a tumor biopsy as judged by the investigator.
* Eastern Cooperative Group (ECOG) performance status ≤ 1 (Karnofsky ≥60%).
* Life expectancy of greater than 90 days, as judged by the investigator.
* Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
* Patients must undergo systemic treatment with gemcitabine or 5-FU 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 tumor biopsy.
* Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the advanced setting.
* Patients who are currently on anti-cancer treatment including chemotherapy.
* Patients with known brain metastases are excluded from participation in this clinical study.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures

Primary outcomes:
measure: Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.
timeFrame: 8 Weeks
Secondary outcomes:
measure: Disease control rate
timeFrame: 4 years
measure: Progression-free survival rate
timeFrame: 4 years
measure: Overall survival rate
timeFrame: 4 years
measure: Genomic predictors of response to chemotherapy identified
timeFrame: 4 years
measure: Germline mutations of hereditary risk factors
timeFrame: 4 years
measure: Potential predictive biomarkers of response to treatment such as BRCA, PALB2 and ATM mutations.
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Jennifer J Knox, M.D.
role: PRINCIPAL_INVESTIGATOR
References: