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Initial Study of Gallbladder Cancer in Chile

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ClinicalTrials.gov Identifier: NCT01520259
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : November 15, 2019
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

- Chile has the highest diagnosis and death rates of gallbladder cancer in the world. Gallbladder cancer is also the leading cause of cancer death in Chilean women. High rates of gallstones and obesity, as well as genetic concerns, may explain these high rates. Researchers want to study gallbladder cancer in more depth in Chile. A small study must be done to see if a full-scale study is feasible.

Objectives:

- To test the methods and procedures of a small-scale study of gallbladder cancer in Chile.

Eligibility:

  • Individuals at least 18 years of age who have gallbladder cancer or gallstones, or are healthy control volunteers.
  • Participants will be recruited from four clinical centers in Chile.

Design:

  • Participants will be screened with a physical exam and medical history. Because gallbladder cancer has a high fatality rate, family members may be asked to provide additional medical history information if study participants die or become too ill to provide this information.
  • Participants will provide blood, urine, stool, hair, fingernail, and saliva samples.
  • Gallstones, bile, and tissue samples will be collected from those who have gallbladder removal surgery. Normal and tumor tissue samples will be collected as needed.
  • Treatment will not be provided as part of this protocol. This is a data collection study only....

Condition or disease
Gallbaldder Cancer

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 446 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Pilot Study of Gallbladder Cancer in Chile
Study Start Date : January 10, 2012

Resource links provided by the National Library of Medicine


Group/Cohort
cases
Women from the cohort with gallbladder cancer
cohort
Women from Chile screened for gallbladder cancer with and without gallstones
controls
Women from the cohort with gallstones



Primary Outcome Measures :
  1. gallbladder cancer/pre-cancer [ Time Frame: ongoing ]
    gallbladder cancer/pre-cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Target neighborhoods in Chile in the study areas.
Criteria

-General Case Eligibility Criteria:

18 or older

no prior cancer diagnosis (except non-melanoma skin cancer)

has gallstones/gallstone disease (including cancer)

able to participate alone or have a proxy (a close family member) answer questions about him/her


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520259


Locations
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Chile
Hospital Regional de Antofagasta
Antofagasta, Chile
Hospital Regional De Concepcion
Concepcion, Chile
Hospital Sorero del Rio
Santiago, Chile
Hospital Regional de Temuco
Temuco, Chile
Sponsors and Collaborators
National Cancer Institute (NCI)
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Jill E. Koshiol, M.D. National Cancer Institute (NCI)

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01520259     History of Changes
Other Study ID Numbers: 999912020
12-C-N020
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: August 8, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gallbaldder
Gallstones
Inflammation
Cholecystectomy
Cancer
Gallbaldder Cancer
Additional relevant MeSH terms:
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Gallbladder Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases