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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00018551 |
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 |
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Colon Cancer Adenoma Colonic Polyps |
Drug: Folic Acid |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Efficacy Study |
Official Title: | 3389 Colorectal Adenoma: Chemoprevention With Folic Acid |
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.
Study ID Numbers: | ONCO-021-98S |
Study First Received: | July 3, 2001 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00018551 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pathological Conditions, Anatomical Vitamin B Complex Digestive System Neoplasms Hematinics Gastrointestinal Diseases Colonic Diseases Colonic Polyps Folate Trace Elements Polyps Folinic Acid Intestinal Diseases |
Vitamin B9 Intestinal Neoplasms Folic Acid Digestive System Diseases Vitamins Gastrointestinal Neoplasms Micronutrients Adenoma Colonic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Pathological Conditions, Anatomical Gastrointestinal Diseases Hematologic Agents Colonic Diseases Physiological Effects of Drugs Polyps Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Digestive System Neoplasms Neoplasms by Histologic Type Vitamin B Complex Hematinics |
Growth Substances Colonic Polyps Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Folic Acid Neoplasms Digestive System Diseases Intestinal Polyps Gastrointestinal Neoplasms Colonic Neoplasms Adenoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |