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Initial Study of Gallbladder Cancer in Chile

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01520259
First received: January 26, 2012
Last updated: November 11, 2014
Last verified: July 2014

January 26, 2012
November 11, 2014
January 2012
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Cancer/Pre-cancer
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Complete list of historical versions of study NCT01520259 on ClinicalTrials.gov Archive Site
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Initial Study of Gallbladder Cancer in Chile
A Pilot Study of Gallbladder Cancer in Chile

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.

We are proposing a pilot study of gallbladder cancer (approximately 120 subjects) in Chile in 2011-2012 to assess the feasibility of conducting a planned full-scale population-based multidisciplinary gallbladder cancer study in Chile. After the completion of the pilot study, we plan to submit a concept to SAG and a proposal to TEP for review/approval of the full-scale study in 2012. It is important and timely to study gallbladder cancer in Chile because this country has the highest reported gallbladder cancer incidence and mortality in the world, with rates that are 6-10 times higher than those reported in the United States. Moreover, gallbladder cancer is the leading cause of cancer death in Chilean women and the third leading cause of cancer death among Chilean men (next to stomach and lung cancer). Reasons for the very high risk of gallbladder cancer in Chile are unclear, although the high prevalence of obesity and gallstones as well as genetic susceptibility have been suggested to explain part of the high risk of gallbladder cancer in this population.

In 2009, NCI and the Chilean government signed a letter of intent to join forces to identify reasons for the high risk of gallbladder cancer in Chile in hopes of developing strategies for cancer prevention. Subsequently, DCEG and NCI s Office of Latin America Cancer Program Development (OLACPD) organized a gallbladder workshop for U.S. and Chilean scientists in Santiago, Chile. Workshop participants concluded that a large-scale multidisciplinary epidemiologic investigation in Chile is urgently needed to clarify risk factors specific to the Chilean population and to help derive preventive strategies to reduce the burden of gallbladder cancer in Chile. Before NCI/DCEG commits substantial resources to support a large field effort, we propose to evaluate the feasibility of successfully carrying out a high quality multidisciplinary epidemiologic study in Chile. We are requesting TEP approval for the This protocol describes a pilot study of gallbladder cancer in Chile with a case-control in four hospitals (120 subjects, including 40 cancer cases, 40 gallstone cases, and 40 population controls) to assess the feasibility of conducting a large study in Chile component, including gallbladder cancer cases, gallstone patients, and population-based controls, and a gallstone expansion recruiting additional patients undergoing cholecystectomy and population-based controls to further explore gallstones in this high-risk population. The total number of participants recruited will be 420.

Observational
Time Perspective: Retrospective
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Gallbaldder Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
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-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

Both
18 Years and older
No
Contact: Ann Hsing, Ph.D. (301) 435-3980 hsinga@exchange.nih.gov
Contact: Jill E. Koshiol, M.D. (301) 402-9508 jk516n@nih.gov
Chile,   Italy
 
NCT01520259
999912020, 12-C-N020
Not Provided
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
Pontificia Universidad Catolica de Chile
Principal Investigator: Jill E. Koshiol, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP