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 #
N01CN075022-004
Application #
2879212
Study Section
Project Start
1997-09-30
Project End
2011-09-29
Budget Start
1998-09-30
Budget End
1999-09-29
Support Year
Fiscal Year
1998
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
Zhu, Claire S; Huang, Wen-Yi; Pinsky, Paul F et al. (2016) The Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) Screening Trial Pathology Tissue Resource. Cancer Epidemiol Biomarkers Prev 25:1635-1642
Kang, Xiaozheng; Liu, Hongliang; Onaitis, Mark W et al. (2016) Polymorphisms of the centrosomal gene (FGFR1OP) and lung cancer risk: a meta-analysis of 14,463 cases and 44,188 controls. Carcinogenesis 37:280-289
Cote, Michele L; Alhajj, Tala; Ruterbusch, Julie J et al. (2015) Risk factors for endometrial cancer in black and white women: a pooled analysis from the Epidemiology of Endometrial Cancer Consortium (E2C2). Cancer Causes Control 26:287-296
Marcus, Pamela M; Broski, Karen G; Buys, Saundra S et al. (2015) Building Successful Relationships in the PLCO Cancer Screening Trial. Rev Recent Clin Trials 10:181-6
Brenner, Darren R; Amos, Christopher I; Brhane, Yonathan et al. (2015) Identification of lung cancer histology-specific variants applying Bayesian framework variant prioritization approaches within the TRICL and ILCCO consortia. Carcinogenesis 36:1314-26
Kvale, Paul A; Johnson, Christine Cole; Tammemägi, Martin et al. (2014) Interval lung cancers not detected on screening chest X-rays: How are they different? Lung Cancer 86:41-6
Wang, Yufei; McKay, James D; Rafnar, Thorunn et al. (2014) Rare variants of large effect in BRCA2 and CHEK2 affect risk of lung cancer. Nat Genet 46:736-41
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:
Patz Jr, Edward F; Pinsky, Paul; Gatsonis, Constantine et al. (2014) Overdiagnosis in low-dose computed tomography screening for lung cancer. JAMA Intern Med 174:269-74
Marcus, Pamela M; Ogden, Sheryl L; Gren, Lisa H et al. (2014) Non-compliance with the initial screening exam visit in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Prev Med 67:82-8

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