The Contractor shall participate in a randomized controlled trial to evaluate screening for prostate cancer using original rectal examination and prostate-specific antigen, screening for lung cancer using chest x- ray, screening for colo-rectal cancer using digital rectal examination and flexible sigmoidoscopy and screening for ovarian cancer using CA 125, transvaginal sonography, and pelvic examination. The Trial protocol was developed during the pilot phase of the Trial, 1992-1995. the contractor shall implement the Trial tasks according to the protocol in the PLCO Cancer Screening Trial manual of Operations and Procedures (MOOP). 1. Identification, entry into the study, nd randomization of at lest 5,000 subjects aged 55-74 into a screened group of 2500 or more individuals. 2. Determination of participant eligibility and baseline characteristics. 3. Obtain local IRB approval for Trial implementation before participant enrollment or randomization to the Trial. 4. Assessment of background level of usage and trend in usage of each screening modality by appropriate surveys in the screening center's catchment region. 5. Provision of screening tests for all four cancer sites. 6. Provision of or referral for diagnostic workups for individuals designated positive by one or more of the screening tests. 7. Provision of cancer incidence and vital status follow-up events for those individuals diagnosed with cancer. 8. Provision of cancer incidence and vital status follow-up procedures for all randomized individuals to determine all instances of cancer diagnosis whether by screening or otherwise. 9. Ascertain all deaths and cause of death. 10. Administration of the study.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN075022-017
Application #
6346658
Study Section
Project Start
1997-09-30
Project End
2014-09-29
Budget Start
2000-08-29
Budget End
2001-09-29
Support Year
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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Gierada, David S; Pinsky, Paul; Nath, Hrudaya et al. (2014) Projected outcomes using different nodule sizes to define a positive CT lung cancer screening examination. J Natl Cancer Inst 106:

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