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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 |