BI-010 as a diagnostic biomarker for cholangiocarcinoma Version 1.0
Research type
Research Study
Full title
BI-010 as a diagnostic biomarker for cholangiocarcinoma
IRAS ID
137022
Contact name
Andrew Metz
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
4 years, 11 months, 29 days
Research summary
Cholangiocarcinoma is a cancer that arises in cells linin the biliary tract. It is the second most common liver cancer, and has a very poor prognosis due to difficulty in diagnosis, late presentation and poor response of tumours to treatment.
The diagnosis of cholangiocarcinoma is difficult.The tumour markers Carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA 19-9) are not specific for cholangiocarcinoma but may be useful in diagnosis, although this needs to be confirmed.
Endoscopic ultrasound-guided fine needle aspirate (EUS-FNA) and ERCP bile duct brushings are the most frequently used methods of obtaining specimens for diagnosis. The sensitivity of these methods is variable, and there is therefore a need for additional tests to improve diagnostic accuracy.
We have identified a potential new biomarker, BI-010, for the diagnosis of cholangiocarcinoma. This study is meant to determine whether BI-010 is a better biomarker for the diagnosis of cholangiocarcinoma either by itself or in combination with the current standard IMP3.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0094
Date of REC Opinion
12 Mar 2015
REC opinion
Favourable Opinion