Risk factors for biliary tract cancer in the United Kingdom Clinical Practice Research Datalink Database

Study type
Protocol
Date of Approval
Study reference ID
17_160
Lay Summary

Biliary tract cancers, which include gallbladder cancer, intrahepatic cholangiocarcinoma (cancer in the liver but arising from the biliary tract), extrahepatic cholangiocarcinoma (cancer in the part of the bile duct that is outside of the liver), and ampulla of Vater cancer (cancer in the last part of the common bile duct, where it passes through the wall of the duodenum and ampullary papilla), are strongly associated with inflammation. For example, gallstones are the major risk factor for gallbladder cancer and cause gallbladder inflammation. Other hypothesized risk factors, such as infections like Salmonella Typhi and Helicobacter species, which are types of bacteria, and obesity/metabolic syndrome, also have an inflammatory component. Aside from the strong association with biliary stones, however, the causes of biliary tract cancers remain largely unknown. A better understanding of the causes of biliary tract cancers may help us find ways to prevent these deadly cancers.

Technical Summary

We propose to describe risk factors for biliary tract cancers using the UK Clinical Practice Research Datalink database (CPRD). In particular, we plan to evaluate the association of anti-inflammatory drugs with risk of biliary tract cancers. We propose a case-cohort approach, wherein we include all biliary tract cancer cases within the CPRD and a random sample of one million CPRD patients. This approach has been successful for past CPRD projects and would facilitate evaluation of time-varying exposures, such as anti-inflammatory drug use. We will use Cox proportional hazard models to calculate by hazard ratios (HRs) and 95% confidence intervals (CI) for anti-inflammatory drugs and type of biliary tract cancer.

Collaborators

Jill Koshiol - Chief Investigator - National Cancer Institute ( NCI )
Jill Koshiol - Corresponding Applicant - National Cancer Institute ( NCI )
Bin Zhu - Collaborator - National Cancer Institute ( NCI )
Lesley Anderson - Collaborator - Queen's University Belfast
Sarah Jackson - Collaborator - National Cancer Institute ( NCI )
Zhiwei Liu - Collaborator - National Cancer Institute ( NCI )

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Practice Level Index of Multiple Deprivation