NIH GUIDE, Volume 23, Number 40, November 18, 1994


P.T. 34




  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



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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