This study is a translational trial of topical all-trans -retinoic acid (atRA) as a chemopreventive for cervical carcinoma utilizing unique intermediate endpoints of reduction in the viral genome copies of HPV per cell coupled with a loss of viral mRNA message. The trial involves the use of three doses levels of atRA applied via a cervical cap for four days to women with biopsy proven CIN II or III. The study participants are then re-examined 12 weeks later for changes in the biomarkers related to dose of atRA. The overall goals are to demonstrate expertise in measuring the biomarkers, determine if atRA modulates the biomarkers and determine the optimal dose of atRA based on modulation of the biomarkers. This study has been peer-reviewed, approved, and funded by the National Cancer Institute.
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