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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00018551 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colon Cancer Adenoma Colonic Polyps |
Drug: Folic Acid |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | 3389 Colorectal Adenoma: Chemoprevention With Folic Acid |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00018551 History of Changes |
| Other Study ID Numbers: | ONCO-021-98S |
| Study First Received: | July 3, 2001 |
| Last Updated: | January 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
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Adenoma Colonic Neoplasms Colonic Polyps Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Intestinal Polyps Polyps Pathological Conditions, Anatomical Folic Acid Hematinics Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematologic Agents Therapeutic Uses |