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Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients

This study is ongoing, but not recruiting participants.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002540
  Purpose

RATIONALE: Screening for cancer may enable doctors to discover and treat the disease earlier.

PURPOSE: Randomized trial to determine if screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers.


Condition Intervention
Colorectal Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Procedure: long-term screening
Procedure: screening questionnaire administration

MedlinePlus related topics:   Cancer    Colorectal Cancer    Lung Cancer    Ovarian Cancer    Prostate Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Screening
Official Title:   PROTOCOL FOR THE NCI PROSTATE, LUNG, COLORECTAL, AND OVARIAN (PLCO) CANCER SCREENING TRIAL

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   November 1993

Detailed Description:

OBJECTIVES: I. Determine whether screening with flexible sigmoidoscopy and chest x-ray can reduce mortality from colorectal and lung cancer, respectively, in men and women aged 55-74. II. Determine whether screening with digital rectal examination (DRE) plus serum prostate-specific antigen (PSA) can reduce mortality from prostate cancer in men aged 55-74. III. Determine whether screening with CA 125 and transvaginal ultrasound can reduce mortality from ovarian cancer in women aged 55-74. IV. Assess other screening variables for each of the above interventions including sensitivity, specificity, and positive predictive value. V. Assess the incidence, stage, and survival experience of cancer cases. VI. Investigate the mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as intermediate endpoints.

OUTLINE: This is a randomized study. Patients are stratified by participating center, gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Patients are randomized to one of two treatment arms. Arm I (Control): Patients receive standard medical care. Arm II: All patients undergo an initial sigmoidoscopic examination and chest x-ray; men also undergo DRE and PSA testing and women undergo a transvaginal ultrasound and CA 125 test. A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for subjects screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal prostate, lung, colorectal, or ovarian cancer (follow-up diagnostic procedures are through their own medical care environment). Patients diagnosed via a screening test with cancer of the prostate, lung, colorectum, or ovary are referred for treatment in accordance with current accepted practice for appropriate stage of disease, patient age, and medical condition; a procedure is provided for contact with qualified medical personnel to insure appropriate therapy. DRE (men only), transvaginal ultrasound (women only), and chest x-ray are repeated annually for 3 years. Patients who have never smoked do not receive a third chest x-ray. PSA testing (men only) and CA 125 tests (women only) are repeated annually for 5 years; the sigmoidoscopic exam is repeated 5 years after the initial exam. A Periodic Survey of Health questionnaire is mailed to each participant annually for 13 years to identify all prevalent and incident cancers of the prostate, lung, colorectum, and ovary as well as all deaths that occur among both screened and control subjects during the trial.

PROJECTED ACCRUAL: A total of 74,000 women and 74,000 men (37,000 for each gender/arm) will be accrued for this study from 10 screening centers (10,000-20,000/center).

  Eligibility
Ages Eligible for Study:   55 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: Men and women aged 55-74 with no known prior cancer of the colon, rectum, lung, prostate, or ovary No routine surveillance for a medical condition involving the above sites No participation in another cancer screening or primary prevention trial

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior or concurrent finasteride for benign prostatic hypertrophy Radiotherapy: Not specified Surgery: No prior surgical removal of the entire colon, one lung, or the entire prostate Other: No concurrent treatment for cancer other than nonmelanomatous skin cancer

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002540

Locations
United States, California
Regents of the University of California    
      Los Angeles, California, United States, 90024
United States, Colorado
University of Colorado Cancer Center    
      Denver, Colorado, United States, 80010
United States, District of Columbia
Lombardi Cancer Center    
      Washington, District of Columbia, United States, 20007
United States, Michigan
Henry Ford Hospital    
      Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Medical School    
      Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine    
      Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
University of Pittsburgh Cancer Institute    
      Pittsburgh, Pennsylvania, United States, 15213-3489
United States, Utah
Huntsman Cancer Institute    
      Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Marshfield Clinic    
      Marshfield, Wisconsin, United States, 54449

Sponsors and Collaborators

Investigators
Study Chair:     Christine D. Berg, MD     NCI - Early Detection Research Group    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Ahn J, Albanes D, Peters U, Schatzkin A, Lim U, Freedman M, Chatterjee N, Andriole GL, Leitzmann MF, Hayes RB; Prostate, Lung, Colorectal, and Ovarian Trial Project Team. Dairy products, calcium intake, and risk of prostate cancer in the prostate, lung, colorectal, and ovarian cancer screening trial. Cancer Epidemiol Biomarkers Prev. 2007 Dec;16(12):2623-30.
 
Andriole GL, Levin DL, Crawford ED, Gelmann EP, Pinsky PF, Chia D, Kramer BS, Reding D, Church TR, Grubb RL, Izmirlian G, Ragard LR, Clapp JD, Prorok PC, Gohagan JK; PLCO Project Team. Prostate Cancer Screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: findings from the initial screening round of a randomized trial. J Natl Cancer Inst. 2005 Mar 16;97(6):433-8.
 
Berndt SI, Huang WY, Chatterjee N, Yeager M, Welch R, Chanock SJ, Weissfeld JL, Schoen RE, Hayes RB. Transforming growth factor beta 1 (TGFB1) gene polymorphisms and risk of advanced colorectal adenoma. Carcinogenesis. 2007 Sep;28(9):1965-70. Epub 2007 Jul 5.
 
Buys SS, Partridge E, Greene MH, Prorok PC, Reding D, Riley TL, Hartge P, Fagerstrom RM, Ragard LR, Chia D, Izmirlian G, Fouad M, Johnson CC, Gohagan JK; PLCO Project Team. Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: findings from the initial screen of a randomized trial. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9. Erratum in: Am J Obstet Gynecol. 2005 Dec;193(6):2183-4.
 
Gohagan JK, Kramer BS, Greenwald P. "Screening for prostate cancer". Am J Prev Med. 1994 Jul-Aug;10(4):245-6. No abstract available.
 
Gohagan JK, Prorok PC, Kramer BS, Cornett JE. Prostate cancer screening in the prostate, lung, colorectal and ovarian cancer screening trial of the National Cancer Institute. J Urol. 1994 Nov;152(5 Pt 2):1905-9.
 
Hayes RB, Sigurdson A, Moore L, Peters U, Huang WY, Pinsky P, Reding D, Gelmann EP, Rothman N, Pfeiffer RM, Hoover RN, Berg CD; for the PLCO Trial Team. Methods for etiologic and early marker investigations in the PLCO trial. Mutat Res. 2005 Dec 30;592(1-2):147-54. Epub 2005 Jul 27.
 
Kirsh VA, Hayes RB, Mayne ST, Chatterjee N, Subar AF, Dixon LB, Albanes D, Andriole GL, Urban DA, Peters U; PLCO Trial. Supplemental and dietary vitamin E, beta-carotene, and vitamin C intakes and prostate cancer risk. J Natl Cancer Inst. 2006 Feb 15;98(4):245-54.
 
Kirsh VA, Peters U, Mayne ST, Subar AF, Chatterjee N, Johnson CC, Hayes RB; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Prospective study of fruit and vegetable intake and risk of prostate cancer. J Natl Cancer Inst. 2007 Aug 1;99(15):1200-9. Epub 2007 Jul 24.
 
Lacey JV Jr, Greene MH, Buys SS, Reding D, Riley TL, Berg CD, Fagerstrom RM, Hartge P. Ovarian cancer screening in women with a family history of breast or ovarian cancer. Obstet Gynecol. 2006 Nov;108(5):1176-84.
 
Miller JH, Kramer BS, Kreimer AR, et al.: Cumulative false-positives (FP) in the prostate, lung, colorectal, ovarian (PLCO) cancer screening trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-1503, 2007.
Moore SM, Gierada DS, Clark KW, Blaine GJ; PLCO-NLST Quality Assurance Working Group. Image quality assurance in the prostate, lung, colorectal, and ovarian cancer screening trial network of the National Lung Screening Trial. J Digit Imaging. 2005 Sep;18(3):242-50.
 
Oken MM, Marcus PM, Hu P, Beck TM, Hocking W, Kvale PA, Cordes J, Riley TL, Winslow SD, Peace S, Levin DL, Prorok PC, Gohagan JK; PLCO Project Team. Baseline chest radiograph for lung cancer detection in the randomized Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. J Natl Cancer Inst. 2005 Dec 21;97(24):1832-9.
 
Partridge E, Kreimer AR, Buys SS, et al.: Ovarian cancer screening in the prostate, lung, colorectal and ovarian cancer screening trial: results from 4 years of annual screening in a randomized trial. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-27, 2007.
Pinsky PF, Andriole GL, Kramer BS, Hayes RB, Prorok PC, Gohagan JK; Prostate, Lung, Colorectal and Ovarian Project Team. Prostate biopsy following a positive screen in the prostate, lung, colorectal and ovarian cancer screening trial. J Urol. 2005 Mar;173(3):746-50; discussion 750-1.
 
Pinsky PF, Crawford ED, Kramer BS, Andriole GL, Gelmann EP, Grubb R, Greenlee R, Gohagan JK. Repeat prostate biopsy in the prostate, lung, colorectal and ovarian cancer screening trial. BJU Int. 2007 Apr;99(4):775-9. Epub 2007 Jan 12.
 
Pinsky PF, Miller A, Kramer BS, Church T, Reding D, Prorok P, Gelmann E, Schoen RE, Buys S, Hayes RB, Berg CD. Evidence of a healthy volunteer effect in the prostate, lung, colorectal, and ovarian cancer screening trial. Am J Epidemiol. 2007 Apr 15;165(8):874-81. Epub 2007 Jan 22.
 
Pinsky PF, Schoen RE, Weissfeld JL, Kramer B, Hayes RB, Yokochi L; PLCO Project Team. Variability in flexible sigmoidoscopy performance among examiners in a screening trial. Clin Gastroenterol Hepatol. 2005 Aug;3(8):792-7.
 
Purdue MP, Mink PJ, Hartge P, Huang WY, Buys S, Hayes RB. Hormone replacement therapy, reproductive history, and colorectal adenomas: data from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial (United States). Cancer Causes Control. 2005 Oct;16(8):965-73.
 
Schoen RE, Weissfeld JL, Kuller LH, Thaete FL, Evans RW, Hayes RB, Rosen CJ. Insulin-like growth factor-I and insulin are associated with the presence and advancement of adenomatous polyps. Gastroenterology. 2005 Aug;129(2):464-75.
 
Tammemagi CM, Freedman MT, Church TR, Oken MM, Hocking WG, Kvale PA, Hu P, Riley TL, Ragard LR, Prorok PC, Berg CD. Factors associated with human small aggressive non small cell lung cancer. Cancer Epidemiol Biomarkers Prev. 2007 Oct;16(10):2082-9.
 
Wang SS, Morton LM, Bergen AW, Lan EZ, Chatterjee N, Kvale P, Hayes RB, Chanock SJ, Caporaso NE. Genetic variation in catechol-O-methyltransferase (COMT) and obesity in the prostate, lung, colorectal, and ovarian (PLCO) cancer screening trial. Hum Genet. 2007 May 12; [Epub ahead of print]
 
Weiss JM, Huang WY, Rinaldi S, Fears TR, Chatterjee N, Hsing AW, Crawford ED, Andriole GL, Kaaks R, Hayes RB. Endogenous sex hormones and the risk of prostate cancer: a prospective study. Int J Cancer. 2008 May 15;122(10):2345-50.
 

Other Publications:

Study ID Numbers:   CDR0000078532, PLCO-1, NCI-P93-0050
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002540
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer  
non-small cell lung cancer  
small cell lung cancer  
rectal cancer  
ovarian epithelial cancer
prostate cancer
ovarian germ cell tumor

Study placed in the following topic categories:
Thoracic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Gastrointestinal Diseases
Gonadal Disorders
Colonic Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Rectal Diseases
Genital Diseases, Female
Respiratory Tract Diseases
Lung Neoplasms
Rectal cancer
Endocrine Gland Neoplasms
Ovarian cancer
Non-small cell lung cancer
Digestive System Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Genital Diseases, Male
Intestinal Diseases
Intestinal Neoplasms
Carcinoma, Small Cell
Digestive System Diseases
Lung Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on August 21, 2008




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