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
screening for prostate cancer ovarian germ cell tumor Small Cell Lung Cancer ovarian epithelial cancer screening for ovarian cancer screening for lung cancer Rectal Cancer screening for colorectal cancer Colon Cancer Non-small cell lung cancer Prostate Cancer

Further Study Details: 

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.

PROTOCOL 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).

Ages Eligible for Study:  55 Years   -   74 Years

Criteria

PROTOCOL ENTRY 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

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

Study chairs or principal investigators

John K. Gohagan,  Study Chair,  National Cancer Institute (NCI)   

Study ID Numbers:  CDR0000078532; PLCO-1; NCI-P93-0050
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002540
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08