Initial Study of Gallbladder Cancer in Chile
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2012 |
We propose a pilot study of gallbladder cancer (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 (to be reviewed if the pilot is successful.)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
-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| 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 | |
| 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 | |
| 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 13, 2013 |
| 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 May 21, 2013