The Randomized 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 through improved triage. The Contractor shall be responsible for overseeing the quality of all aspects of the Trial involving HPV testing. Prior to enrollment, the Contractor shall choose optimal HPV DNA testing methods, assess the qualifications of testing laboratories, and validate the performance of participating laboratories. During the conduct of the Trial, the Contractor shall monitor and optimize all aspects of the Trial Procedures Manual related to HPV DNA testing including the design and conduct of masked quality control experiments and the performance of repeat """"""""in- house"""""""" testing of specimens. The Contractor shall cooperate with the Study's Coordinating Unit, Clinical Centers, Quality Control Groups, consultants, and the National Cancer Institute Project Officers.
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