RANDOMIZED TRIAL ON THE CLINICAL MANAGEMENT OF ASCUS

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The Randomized Trial on the Clinical Management of ASCUS and LSIL of the Uterine Cervix is designed to: l) Determine whether human papillomavirus(HPV) testing can effectively triage women with a cytologic diagnosis of ASCUS (atypical squamous cells of undetermined significance) or LSIL (low-grade squamous intraepithelial lesion) 2) Develop clinical management guidelines and provide prognostic information for the ASCUS and LSIL diagnostic categories of the Bethesda System, and 3) Determine whether the cost of screening and treatment for the potential precursor lesions of cervical cancer can be reduced though improved triage. The Contractor shall be responsible for overseeing the quality of all aspects of the Trial involving cytology and histopathology. The Contractor shall review all referral and enrollment smears and all histology slides, as well as selected follow-up cytology smears taken during the Trial at the Clinical Centers. The Contractor shall conduct consensus meetings among the Clinical Center pathologists and during the conduct of the Trial monitor and optimize all aspects of the Protocol related to pathology. The Contractor shall cooperate with the Study's Coordinating Unit, Clinical Centers, Quality Control Groups, consultants, and the National Cancer Institute Project Officers.