Skip to main content
OpenTrials
Completed

NCT Number: NCT00339560

A Population-Based Case-Control Study of Biliary Tract Cancers in Shanghai, China

The key aims of this study include estimation of possible risk associated with a history of gallstones, bacterial infection for the biliary tract, other medical history, diet, use of tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence of bacteria infection. A major challenge in biliary tract cancer research is to determine how cancer risk factors differ from those for gallstones or biliary duct stone disease, since many people have gallstones (or biliary duct stones) but few develop cancer....

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Cancer Institute

Shanghai, China

About this study

The key aims of this study include estimation of possible risk associated with a history of gallstones, bacterial infection for the biliary tract, other medical history, diet, use of tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence of bacteria infection. A major challenge in biliary tract cancer research is to determine how cancer risk factors differ from those for gallstones or biliary duct stone disease, since many people have gallstones (or biliary duct stones) but few develop cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

Cases of biliary tract cancer newly diagnosed between September 1, 1996 and August 31, 1999 among residents of urban Shanghai.

Must be under the age of 75 at the time of diagnosis.

Treatment and study plan

Primary outcomes

  1. Gallbladder Cancer

    Time frame: 5 years

    Gallbladder cancer

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Important dates

Study start
1997
Primary completion
2008
Study completion
2008
First posted
Jun 21, 2006
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.