Initial Study of Gallbladder Cancer in Chile

This study is currently recruiting participants.
Verified August 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01520259
First received: January 26, 2012
Last updated: March 14, 2014
Last verified: August 2013
  Purpose

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
Gallbaldder Cancer
Gallstones

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pilot Study of Gallbladder Cancer in Chile

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 420
Study Start Date: January 2012
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520259

Contacts
Contact: Ann Hsing, Ph.D. (301) 435-3980 hsinga@exchange.nih.gov
Contact: Jill E. Koshiol, M.D. (301) 402-9508 jk516n@nih.gov

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

No publications provided

ClinicalTrials.gov Identifier: NCT01520259     History of Changes
Other Study ID Numbers: 999912020, 12-C-N020
Study First Received: January 26, 2012
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Chili
Pilot Study
Gallbaldder Cancer
Gallstones
Mapuche

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Gallbladder Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014