REG-Bil
Research type
Research Study
Full title
REG-Bil: clinical REGistry and molecular characterisation of BILiary Tract Cancers
IRAS ID
276732
Contact name
Chiara Braconi
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Biliary Tract Cancers (BTC) are tumours arising from the lining of bile ducts and can emerge at every point of the biliary tree. All together, 5 sub-types of BTCs are described. According to the anatomical location, BTCs are classified into intrahepatic, perihilar and distal cholangiocarcinoma, Gallbladder Cancer and Ampullary Cancer. These subtypes of BTCs have particular similarities but also important differences that can affect their clinical behaviour. Incidence of BTC is increasing all around the world with regional differences in distribution of subtypes according to risk factors.
In this study we aim to collect clinical data of all patients with a diagnosis of BTCs in order to define the characteristics of the BTC population seen at the NHS GGC trust and to define the overall survival in this population. Secondary objectives will include disease free survival (DFS) in patients undergoing radical surgery, chemotherapy outcome (response rate, progression free survival), and the proportion of subtypes and analyse DFS and OS for each subtype.
All patients >18 yrs old with a radiological diagnosis of BTCs from 2020 to 2024 are eligible. Collection of clinical information and retrieval of archival tissue will be pursued, in association with collection of blood, urine, bile, and fresh tissue when possible. Study of the characteristics of the tumour (i.e. site and size of the tumour), of the genetic differences (DNA and RNA, which contain a code that controls how cells grow and divide), and of circulating molecules (proteins, RNA, metabolites) that are present in the body of BTC patients may help us explain the differences in the clinical behaviours of BTCs, and may help the future development of more personalised treatment.REC name
South West - Frenchay Research Ethics Committee
REC reference
20/SW/0054
Date of REC Opinion
2 Jul 2020
REC opinion
Further Information Favourable Opinion