RANDOMIZED TRIAL ON CLINICAL MANAGEMENT OF ASCUS AND LSIL OF THEUTERINE CERVIX - CLINICAL CENTERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFP AVAILABLE: NCI-CN-55040-05 P.T. 34 Keywords: Cancer/Carcinogenesis Clinical Trial Data Management/Analysis+ National Cancer Institute The proposed project is a three-armed clinical trial of 6 years duration involving 7,200 females aged 16 and over. The subjects will be randomized to one of three arms, each containing 2,400 females. Each clinical center should be able to recruit a minimum of 1,200 randomized subjects within a maximum time period of 18 months. Of the 1,200 recruited subjects, 600 subjects shall have recently diagnosed LSIL (low-grade squamous intraepithelial lesion) and 600 subjects shall have ASCUS (atypical squamous cells of undetermined significance). The offeror must document their referral base of ASCUS/LSIL diagnosed patients for the past year (1993). The trial goals and major objectives are as follows: (1) to determine whether human papillomavirus (HPV) DNA testing can effectively triage women with a cytologic diagnosis of ASCUS or LSIL; (2) to develop clinical management guidelines and provide prognostic information for the ASCUS and LSIL diagnostic categories of the Bethesda System; and (3) to determine whether the cost of screening and treatment for the potential precursor lesions of cervical cancer can be reduced through improved triage. INQUIRIES Request for this solicitation must be in writing and must reference the RFP number, NCI-CN-55040-05. The RFP is tentatively scheduled for release on December 1, 1994 with proposals due approximately January 30, 1995. Four to six awards are anticipated. No collect calls will be accepted. Requests should be mailed to: Gary Topper Research Contracts Branch, PCCS National Cancer Institute 6120 Executive Boulevard Bethesda, MD 20892-7226 Telephone: (301) 496-8603 .
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