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Chemoprevention With Folic Acid

This study has been completed.
Information provided by Department of Veterans Affairs

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Descriptive Information Fields
Brief Title  Chemoprevention With Folic Acid
Official Title  3389 Colorectal Adenoma: Chemoprevention With Folic Acid
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.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Prevention, Randomized, Double-Blind, Placebo Control, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Colon Cancer
Adenoma
Colonic Polyps
Intervention  Drug: Folic Acid
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  October 1998
Completion Date September 2003
Eligibility Criteria 

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.

Gender Both
Ages 18 Years to 80 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00018551
Organization ID ONCO-021-98S
Secondary IDs ††
Study Sponsor  Department of Veterans Affairs
Collaborators ††
Investigators 
Information Provided By Department of Veterans Affairs
Verification Date December 2004
First Received Date  July 3, 2001
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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