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Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial

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.
 
ClinicalTrials.gov Identifier: NCT00339495
Recruitment Status : Active, not recruiting
First Posted : June 21, 2006
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

The Division of Cancer Preventionl (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 selected 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, withconfirmation of disease status from medical records. Genetic, biochemical and questionnairebasedrisk 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. 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.


Condition or disease
Cancer Death

Detailed Description:

The Division of Cancer Preventionl (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 selected 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, withconfirmation of disease status from medical records. Genetic, biochemical and questionnairebasedrisk 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. 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.

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Study Type : Observational
Actual Enrollment : 154900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial
Actual Study Start Date : May 1, 1998

Resource links provided by the National Library of Medicine


Group/Cohort
Non-Screening
Participants received their usual care
Screening
Participants received trial-provided screening examinations for prostate, lung, colorectal, and ovarian cancer



Primary Outcome Measures :
  1. Death [ Time Frame: Extended beyond T13 ]
    Death

  2. Cancer incidence [ Time Frame: Extended beyond T13 ]
    Cancer Incidence



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community samples from ten US screening centers: Birmingham AL, Denver CO, Detroit MI, Honolulu HI, Marshfield WI, Minneapolis MN, Pittsburgh PA, Salt Lake City UT, St Louis MO, and Washington DC
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.


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
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United States, Maryland
Westat, Inc.
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Neal D Freedman, M.D. National Cancer Institute (NCI)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00339495    
Other Study ID Numbers: 999997041
OH97-C-N041
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 22, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Prostate
Screening Trial
Ovarian
Lung
Colorectal