CClinicalTrials.gg
CompletedNCT00339560Updated Jun 16, 2020

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

An observational study in Biliary Tract Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,624
Ages
18 Years to 75 Years
Sex
All
01

Study 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....

Read the 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.

02

Conditions studied

  • Biliary Tract Cancer

Keywords

  • Ampulla of Vater
  • Gallbaldder
  • Cancer
  • Extrahepatic Bile Duct
03

In context

Biliary Tract Neoplasms

484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.

This study's enrollment of 2,624 is above the median of 160 across 67 observational studies indexed under Biliary Tract Neoplasms.

Browse Biliary Tract Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Residents of Shanghai.

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.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,624 participants (actual)

Groups and cohorts

  • Cases will bile duct CA

    Patients with bile duct cancer

  • Cases with Gallbladder CA

    Patients with gallbladder cancer

  • Controls with gall stones

    Patients undergoing cholecystectomy for gall stones

  • Controls without cancer

    Hospital controls with cancer

06

What researchers measure

Primary outcomes

  1. Gallbladder Cancer

    Gallbladder cancer

    Time frame: 5 years

07

Study locations

1 site
  • Shanghai Cancer Institute
    Shanghai, China
08

References and documents

Publications

  • 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. PubMed 4027991 ↗
  • 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. PubMed 8449600 ↗
  • 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. PubMed 3309421 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00339560
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 21, 2006
Start date
May 16, 1997
Primary completion
May 21, 2008
Completion
May 21, 2008
Last update
Jun 16, 2020

Study contacts

Jill E. Koshiol, M.D.
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion