RANDOMIZED TRIAL ON THE CLINICAL MANAGEMENT OF ASCUS

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TheRandomized Trial on the Clinical Management of ASCUS and LSIL of the Uterine Cervix is designed to: 1) 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 all aspects of the Trial involving direct contact with patients including patient outreach and recruitment, provision of screening tests and study interviews, randomization into one of three management study arms, and provision of followup and treatment based on study protocols. As a member of the Study Steering Committee, The Contractor shall assist the preparation of a Procedures Manual to include the final protocol, data systems design, and study forms. The Contractor shall cooperate with the Study's three quality control groups, consultants, Coordinating Unit, and National Cancer Institute Project Officers.