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Chemoprevention With Folic Acid

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ClinicalTrials.gov Identifier: NCT00018551
Recruitment Status : Completed
First Posted : July 5, 2001
Last Update Posted : January 21, 2009
Information provided by:
VA Office of Research and Development

Brief Summary:
Colorectal neoplasia is the second most common cancer in the United States and other Western countries with about 140,000 newly diagnosed cases per year in the United States with a mortality rate of about 40%. The identification of a specific natural or synthetic compound with the ability to reverse or suppress the process of colon carcinogenesis would have profound implication in the development of colorectal adenomas and their subsequent transformation to colon cancer. Furthermore, the establishment of a correlative relationship between biomarkers of cell proliferation, differentiation, apoptosis and adenoma recurrence would provide pivotal data required to elucidate cell signaling mechanisms in future colon cancer chemoprevention trials.

Condition or disease Intervention/treatment Phase
Colon Cancer Adenoma Colonic Polyps Drug: Folic Acid Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: 3389 Colorectal Adenoma: Chemoprevention With Folic Acid
Study Start Date : October 1998
Estimated Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Asymptomatic individuals from the age of 18 -80 years, undergoing clinically indicated colonoscopy for colon polyps noted on screening flexible sigmoidoscopy or as routine surveillance for a history of colon polyps, who are found to have at least one adenoma > 0.5cm will be eligible for entry.

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): NCT00018551

United States, Michigan
Department of Veterans Affairs
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
VA Office of Research and Development

ClinicalTrials.gov Identifier: NCT00018551     History of Changes
Other Study ID Numbers: ONCO-021-98S
First Posted: July 5, 2001    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: December 2004

Additional relevant MeSH terms:
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Polyps
Pathological Conditions, Anatomical
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs