Clinical trial NCT00339560: A Population-Based Case-Control Study of Biliary Tract Cancers in Shanghai, China
Official title: A Population-Based Case-Control Study of Biliary Tract Cancers in Shanghai, China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Tract Cancer
Keywords: Ampulla of Vater
Gallbaldder
Cancer
Extrahepatic Bile Duct
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 2624
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Shanghai.

Brief 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....

Detailed 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Gallbladder Cancer
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Institute
Study officials:
affiliation: National Cancer Institute (NCI)
name: Jill E. Koshiol, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1002/ijc.2910530510.
citation: 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.