RANDOMIZED TRIAL ON THE CLINICAL MANAGEMENT OF ASCUS AND

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。 承包商应负责试验的所有方面， 与患者直接接触，包括患者外展和招募， 提供筛选测试和研究访谈，随机分为 三个管理研究组，并提供随访和治疗 根据研究方案。 作为研究指导委员会的成员， 承包商应协助编制程序手册， 包括最终方案、数据系统设计和研究表格。 的 承包商应与研究的三个质量控制小组合作， 顾问、协调单位和国家癌症研究所项目 军官

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 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.