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Early Marker and Etiologic Studies in the PLCO Trial
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00339495
  Purpose

The Division of Cancer Prevention and Control (DCPC), under extramural contracts to 10 U.S. clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal and ovarian cancer (The PLCO Trial). The NCI Executive Committee approved the expansion of the PLCO Trial to collect additional materials and to conduct additional studies. About 74,000 men and 74,000 women, aged 55-74 years, are being randomized on a 50/50 basis into screening or usual care arms. Additional blood will be collected from screened subjects and saliva for buccal cells from control subjects. Pathologic tissues will be obtained for cases that develop cancer or selected related diseases (e.g., colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk information will also be collected. Genetic, biochemical and questionnaire-based risk information will be related to the development of cancer and other diseases in this population. Volunteers who provide samples for these studies will not routinely receive their individual results from the Additional Investigation. Subjects requesting such information, however, will be provided their test results. This protocol Review Application is for the collaboration of intramural scientists in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies.


Condition
Cancer

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Early Marker and Etiologic Studies in the PLCO Trial

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 156000
Study Start Date: July 1997
Detailed Description:

The Division of Cancer Prevention and Control (DCPC), under extramural contracts to 10 U.S. clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal and ovarian cancer (The PLCO Trial). The NCI Executive Committee approved the expansion of the PLCO Trial to collect additional materials and to conduct additional studies. About 74,000 men and 74,000 women, aged 55-74 years, are being randomized on a 50/50 basis into screening or usual care arms. Additional blood will be collected from screened subjects and saliva for buccal cells from control subjects. Pathologic tissues will be obtained for cases that develop cancer or selected related diseases (e.g., colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk information will also be collected. Genetic, biochemical and questionnaire-based risk information will be related to the development of cancer and other diseases in this population. Volunteers who provide samples for these studies will not routinely receive their individual results from the Additional Investigation. Subjects requesting such information, however, will be provided their test results. This protocol Review Application is for the collaboration of intramural scientists in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies.

  Eligibility

Ages Eligible for Study:   55 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Men and women aged 55-74 years.

Subjects who do not have a prior history of PLCO tumors and have not undergone routine screening.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00339495

Locations
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80220-3706
Sponsors and Collaborators
  More Information

Study ID Numbers: 999997041, OH97-C-N041
Study First Received: June 19, 2006
Last Updated: November 21, 2008
ClinicalTrials.gov Identifier: NCT00339495  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cancer
Risk Factors
Prospective Study
Chronic Disease
Molecular Epidemiology

Study placed in the following topic categories:
Chronic Disease

ClinicalTrials.gov processed this record on January 14, 2009