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Initial Study of Gallbladder Cancer in Chile

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520259
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : August 4, 2020
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- 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.


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


  • 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.


  • 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

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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

Women from the cohort with gallbladder cancer
Women from Chile screened for gallbladder cancer with and without gallstones
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

-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 identifier (NCT number): NCT01520259

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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
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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) Identifier: NCT01520259    
Other Study ID Numbers: 999912020
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: August 4, 2020
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 Cancer
Additional relevant MeSH terms:
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Gallbladder Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases