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	Treatment or Intervention	Phase
Colon Cancer Adenoma Colonic Polyps	Drug: Folic Acid	Phase II

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Michigan
      Department of Veterans Affairs, Detroit,  Michigan,  48201,  United States; Recruiting

Study ID Numbers:  ONCO-021-98S
Record last reviewed:  June 2001
Record first received:  July 3, 2001
ClinicalTrials.gov Identifier:  NCT00018551
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09