RANDOMIZED TRIAL ON THE CLINICAL MANAGEMENT OF ASCUS

ASCUS和LSIL临床处理的随机试验 子宫颈检查旨在：l）确定人类是否 乳头瘤病毒（HPV）检测可以有效地分流妇女与细胞学检查， 诊断ASCUS（意义不明的非典型鳞状细胞） 或LSIL（低度鳞状上皮内病变）2）发展临床 管理指南，并为ASCUS提供预后信息， Bethesda系统的LSIL诊断类别，以及3）确定 筛选和处理潜在前体的费用 改善分流方法可减少子宫颈癌的病变。 承包商应负责监督所有 涉及细胞学和组织病理学的试验方面。承包商 应审查所有转诊和入组涂片以及所有组织学切片， 以及在试验期间采集的选定随访细胞学涂片， 临床中心。 承包商应召开协商一致会议 临床中心病理学家之间以及试验实施期间 监测和优化与病理学相关的方案的所有方面。 承包商应与研究协调单位合作， 临床中心、质量控制小组、顾问和国家 癌症研究所项目官员。

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.