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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
A type of surgical procedure that will use a thin needle to remove a sample of tumor tissue.
Blood will be taken by a needle from a vein.
A sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected.
Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.
Time frame: 8 Weeks
Disease control rate
Time frame: 4 years
Progression-free survival rate
Time frame: 4 years
Overall survival rate
Time frame: 4 years
Genomic predictors of response to chemotherapy identified
Time frame: 4 years
Germline mutations of hereditary risk factors
Time frame: 4 years
Potential predictive biomarkers of response to treatment such as BRCA, PALB2 and ATM mutations.
Time frame: 4 years
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