RANDOMIZED TRIAL ON THE CLINICAL MANAGEMENT OF

临床管理的随机试验

• 批准号: 2302618
• 负责人: Cosette M Wheeler
• 金额: $ 42.52万
• 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/2302618
• 关键词: RANDOMIZED; TRIAL; CLINICAL; MANAGEMENT

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.

ASCUS 和 LSIL 临床治疗的随机试验 子宫颈旨在： 1) 确定是否存在人乳头瘤病毒 （HPV）检测可以有效地对细胞学诊断为以下类型的女性进行分类： ASCUS（意义未明的非典型鳞状细胞）或 LSIL（低- 级鳞状上皮内病变），2）制定临床管理 为 ASCUS 和 LSIL 提供指南并提供预后信息 Bethesda 系统的诊断类别，以及 3) 确定是否 潜在前驱病变的筛查和治疗费用 通过改进分诊可以减少宫颈癌的发生。 承包商应负责监督所有的质量 试验涉及 HPV 检测的各个方面。 在入学之前， 承包商应选择最佳的 HPV DNA 检测方法，评估 测试实验室的资质，并验证其性能 参与实验室。 在审判进行期间， 承包商应监控和优化试验程序的各个方面 与 HPV DNA 检测相关的手册，包括设计和实施 掩蔽质量控制实验和重复“in- 房屋”样本测试。承包商应配合 研究协调单位、临床中心、质量控制小组、 顾问和国家癌症研究所项目官员。