Biliary Tract Cancer
Conditions
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.
Interventions
PROCEDUREFresh tumor tissue biopsy
A type of surgical procedure that will use a thin needle to remove a sample of tumor tissue.
PROCEDUREBlood draw
Blood will be taken by a needle from a vein.
PROCEDUREArchival tumor tissue collection
A sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy. | 8 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival rate | 4 years |
| Overall survival rate | 4 years |
| Disease control rate | 4 years |
| Germline mutations of hereditary risk factors | 4 years |
| Potential predictive biomarkers of response to treatment such as BRCA, PALB2 and ATM mutations. | 4 years |
| Genomic predictors of response to chemotherapy identified | 4 years |
Outcome results
None listed