NOT-CA-02-011: DEFINING AND VALIDATING BIOMARKERS OF RISK FOR PROGRESSIVE CERVICAL CANCER

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®


DEFINING AND VALIDATING BIOMARKERS OF RISK FOR PROGRESSIVE CERVICAL CANCER

Release Date:  January 9, 2002

NOTICE:  NOT-CA-02-011

National Cancer Institute

The Division of Cancer Epidemiology 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 progressive 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 numbers 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 swabs) 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 No. N02-CP-21005-
50) package will be available on or about January 15, 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 30, 2002.

INQUIRIES

For further information, contact:

Karen L. McFarlane
Contracting Officer
Epidemiology and Support Section, RCB
Executive Plaza South
6120 Executive Boulevard
Rockville, MD  20892-7224
email:  [email protected]
Voice:  (301) 435-3782
Fax:  (301) 480-0241
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices