CHEMOPREVENTION (OR PREVENTION) OF CERVICAL CANCER WITH FOLIC ACID

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This is a proposal for the continuation of a study originally funded in the first CPRU Program Project Grant. The Chemoprevention of Cervical Cancer with Folic Acid Study (CCCFAS) is presently in its second year of patient accrual. The purpose of this double-blind randomized-controlled trial is to determine the effectiveness of oral folic acid therapy in preventing the development of cervical cancer in high-risk patients (those women with biopsy-proven mild or moderate dysplasia or koliocytotic atypia). The major study endpoint is the regression of dysplasia which is ascertained by PAP smear and colposcopy. A continuation was made necessary because of a delay of over two years in beginning patient accrual, due to the inability of the NCI and its contractor to provide the folic acid and placebo tablets and the lengthy FDA approval process.