PATHOLOGY QUALITY CONTROL GROUP FOR THE ASCUS/LSIL CLINICALMANAGEMENT TRIAL NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFP AVAILABLE: NCI-CN-55043-05 P.T. 34 Keywords: Cancer/Carcinogenesis Pathophysiology Clinical Trial National Cancer Institute The National Cancer Institute, Division of Cancer Prevention and Control, is soliciting proposals for a Pathology Quality Control (QC) Group that will assure the reliable and accurate use of the Bethesda System for cytology and the cervical intra-epithelial neoplasia (CIN) scale for histopathology for a randomized clinical management trial among 3,600 women with the cervical cytologic diagnoses of "atypical squamous cells of undetermined significance" (ASCUS) and 3,600 women with "low-grade squamous intra-epithelial lesions" (LSIL). The Pathology QC Group shall be responsible for overseeing the quality of all aspects of the Trial involving cytology and histopathology. The general requirements include: (1) preparation with the other collaborators of the final protocols, data systems, and study forms; specifically, identifying the optimal protocol for the collection, fixation, staining, storing, and transport of cytologic and histologic specimens; (2) prior to enrollment, minimizing the intra- and inter-laboratory variability of cytologic and histologic diagnoses from the cooperating Pathology Laboratories used by the Clinical Centers during the Trial; (3) during the conduct of the Trial, continuing to monitor and optimize all aspects of the Protocol related to pathology, including review of all 7,200 referral cytology smears, all 7,200 enrollment smears, and a large sample (about 1,000 per year) of the follow-up cytology smears at the Clinical Centers; (4) review of all histology slides collected in the Trial (estimated for budgetary purposes at about 8,000 cases over the course of the study) to standardize clinical outcomes and provide quality control, including the design and conduct or masked quality control experiments; (5) ongoing participation in the overall supervision of the Trial via the Steering Committee and its subcommittees; and (6) cooperation with all Trial administrative functions, including reporting, data management, and proper handling of Trial-related biospecimens. INQUIRIES Requests for this solicitation must be in writing and reference the RFP Number, NCI-CN-55043-05. The RFP is tentatively scheduled for release on December 1, 1994. No collect calls will be accepted. Requests should be mailed to: Gary Topper Research Contracts Branch, PCCS National Cancer Institute Executive Plaza South, Room 635 6120 Executive Boulevard, MSC 7226 Bethesda, MD 20892-7226 Telephone: (301) 496-8603 .
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