Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00339495 |
| Other study ID # |
999997041 |
| Secondary ID |
OH97-C-N041 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 1998 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
January 26, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
