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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339560
• Other study ID #: 999997028
• Secondary ID: OH97-C-N028
• Status: Completed
• Start date: May 16, 1997
• Est. completion date: May 21, 2008

Study information

• Verified date: June 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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....

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2624
• Est. completion date: May 21, 2008
• Est. primary completion date: May 21, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Locations

Country	Name	City	State
China	Shanghai Cancer Institute	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

China, 

References & Publications (3)

Devesa SS, Silverman DT, Young JL Jr, Pollack ES, Brown CC, Horm JW, Percy CL, Myers MH, McKay FW, Fraumeni JF Jr. Cancer incidence and mortality trends among whites in the United States, 1947-84. J Natl Cancer Inst. 1987 Oct;79(4):701-70. Review. — View Citation

Jin F, Devesa SS, Zheng W, Blot WJ, Fraumeni JF Jr, Gao YT. Cancer incidence trends in urban Shanghai, 1972-1989. Int J Cancer. 1993 Mar 12;53(5):764-70. — View Citation

Strom BL, Hibberd PL, Soper KA, Stolley PD, Nelson WL. International variations in epidemiology of cancers of the extrahepatic biliary tract. Cancer Res. 1985 Oct;45(10):5165-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gallbladder Cancer	Gallbladder cancer	5 years