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Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients Clinical research trials and Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients. Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients clinical trial. Participants frequently get the best healthcare available for their Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients  Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
For 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
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
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).
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 55 Years/74 Years
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGohagan, Study Chair, National Cancer Institute (NCI)
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Marshfield Clinic
Marshfield, Wisconsin, 54449
United States
Regents of the University of California
Los Angeles, California, 90024
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Additional Information:
Study ID Numbers: CDR0000078532; PLCO-1,NCI-P93-0050
Study Start Date: November 1993
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002540
Other Screening For Prostate Cancer Studies:
1. Combination Chemotherapy and Oblimersen in Treating Patients With Advanced Colorectal Cancer
2. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
3. Computed Tomographic Colonography in Detecting Colorectal Polyps or Cancer
4. Biological Therapy in Treating Patients With Metastatic Cancer
5. Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
Related Studies:
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Other California Clinical Trials
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Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
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