RANDOMIZED TRIAL ON THE CLINICAL MANAGEMENT OF

临床管理的随机试验

• 批准号: 6087740
• 负责人: Cosette M Wheeler
• 金额: $ 10万
• 依托单位: UNIVERSITY OF NEW MEXICO
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至 2001-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6087740
• 关键词: cervix neoplasms; clinical trials; cytodiagnosis; diagnosis quality /standard; early diagnosis; female; health care cost /financing; human papillomavirus; human subject; neoplasm /cancer diagnosis; prognosis; squamous cell carcinoma; uterus preneoplastic state; virus DNA; virus related neoplasm /cancer

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.

关于ASCUS和LSIL临床管理的随机试验 子宫宫颈旨在：1）确定人乳头瘤病毒是否是否 （HPV）测试可以有效地分类女性，并具有细胞学诊断 Ascus（不确定意义的非典型鳞状细胞）或LSIL（低 - 等级鳞状上皮病变），2）发展临床管理 指南并为ASCUS和LSIL提供预后信息 贝塞斯达系统的诊断类别，3）确定是否确定 筛查和治疗的潜在前体病变的成本 宫颈癌可以通过改善的分类降低。 承包商应负责监督所有人的质量 涉及HPV测试的试验方面。 入学之前， 承包商应选择最佳的HPV DNA测试方法，评估 测试实验室的资格，并验证表现 参与实验室。 在进行试验期间， 承包商应监视和优化试验程序的所有方面 与HPV DNA测试有关的手册，包括设计和行为 掩盖质量控制实验和重复“ 房屋“标本测试。承包商应与 研究的协调单元，临床中心，质量控制组， 顾问和国家癌症研究所项目官员。