B -- DEFINING AND VALIDATING BIOMARKERS OF RISK FOR PROGRESSIVE CERVICAL CANCER

Notice Date

December 12, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Room 604, Rockville, MD, 20852

ZIP Code

20852

Solicitation Number

N02-CP-21005-66

Response Due

February 15, 2002

Point of Contact

Shawnee Shaw, Contract Specialist, Phone (301) 435-3778, Fax (301) 480-0241, Email ss552u@nih.gov -- Sharon Miller, Contracting Officer, Phone (301) 435-3783, Fax (301) 480-0241, Email sm103r@nih.gov

Description

The Division of Cancer Epidemilogy and Genetics (DCEG), Environmental Epidemiology Branch (EEB) of the National Cancer Institute is conducting a study to collect and store cervical tissue specimens that will be used for DNA and RNA analyses, in women representative of the four natural history categories in cervical neoplasia: normal, HPV-positive, precancer, and cancer. The main focus of the study is to identify and validate biomarkers at different stages of cervical neoplasia that may be predictive of disease. The proposed study will consist of two components: a cross-sectional component and a prospective component. The cross-sectional design will be used to identify candidate biomarkers of risk at each neoplastic stage. Based on the candidate markers generated from this analysis, their predictive value in progression and regression from HPV infection will be confirmed in the prospective design for the key intermediate outcomes: HPV clearance, HPV persistence, and progression to precancer. The entire study duration is planned for five years; we anticipate a 6-month start-up period, a 2-4 year recruitment of eligible women (2 years for normal and HPV-positive women, and up to 4 years to accrue adequate number of cancers and precancers), a 2-year follow-up period for HPV-positive women, and a 6-month close-out period. From each participant, a short interview will be conducted to assess known HPV co-factors, and biological specimens (blood, cervical secretions, cervical swab) in addition to the biopsied cervix tissue will be collected. Intramural investigators at the National Cancer Institute (NCI) are implementing this effort to identify key biomarkers with potential prognostic value in cervical neoplasia. This work pertains to the implementation and conduct of the field effort to this study. It is anticipated that the Request for Proposal (RFP) package will be available on or about January 14,2002 with responses due within 30 calendar days following the actual date of issuance of the RFP. The RFP may be accessed via the NCI Research Contracts Branch (RCB) website: http://rcb.nci.nih.gov/ under "Current Requests for Proposals". Award of this project is anticipated by June, 2002. All responsible sources may submit a proposal that shall be considered by the NCI. No collect calls will be accepted. =20

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/NIH/RCB/N02-CP-21005-66/listing.html)

Record

Loren Data Corp. 20011214/BSOL002.HTM (D-346 SN515072)