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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