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Early Marker and Etiologic Studies in the PLCO Trial

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00339495
First Posted: June 21, 2006
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  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 Death

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Etiologic and Early Marker Studies in the PLCO Trial

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

Primary Outcome Measures:
  • Death [ Time Frame: Extended beyond T13 ]
  • Cancer incidence [ Time Frame: Extended beyond T13 ]

Estimated Enrollment: 156000
Study Start Date: July 21, 1997
Detailed Description:

The Division of Cancer Prevention and Control (DCP, formerly 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). In 1996 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, have been randomized on a 50/50 basis into screening or usual care arms. Additional blood is collected from screened subjects and saliva for buccal cells from control subjects. Pathologic tissues are obtained for cases that develop cancer or selected related diseases (e.g., colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk and disease-related information is also collected, with confirmation of disease status from medical records. 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 with the research results. In 2009 the NCI Executive Committee approved the Extended Follow-up of subjects beyond the original 13-year follow-up period. Participants will be reconsented for the release of records to a single NCI-Designated Central Data Collection Center (CDCC), which will administer the annual mailings containing the annual study update questionnaire and a brief (1-2 page) risk factor questionnaire. Individuals who do not consent to release their identifiers to the CDCC will be followed up passively through linkage to state cancer registries and the National Death Index.

This protocol Review Application is for (1) the collaboration of intramural scientists in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies and (2) the coordination, in collaboration with DCP, of the Extended Follow-up.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00339495


Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert N Hoover, M.D. National Cancer Institute (NCI)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00339495     History of Changes
Other Study ID Numbers: 999997041
OH97-C-N041
First Submitted: June 19, 2006
First Posted: June 21, 2006
Last Update Posted: October 6, 2017
Last Verified: September 6, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Prostate
Screening Trail
Ovarian
Lung
Colorectal