CLINICAL MANAGEMENT OF ASCUS/LSIL OF THE UTERINE CERVIX

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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 establish a Study Coordinating and Data Management Unit (CU) for the Trial to develop and maintain systems and procedures needed for biomedical data management, study coordination, statistical analysis and report writing. The CU in its coordination efforts shall act as a liaison between the Clinical Centers, the Quality Control Groups, study consultants, and the National Cancer Institute Project Officers.