Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339495
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2006-06-19
Brief Title:
Prostate Lung Colorectal and Ovarian PLCO Cancer Screening Trial
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prostate Lung Colorectal and Ovarian PLCO Cancer Screening Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Division of Cancer Preventionl DCP formerly DCPC under extramural contracts to 10 US 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 74000 men and 74000 women aged 55-74 years have been randomized on a 5050 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 eg 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
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
Detailed Description:
The Division of Cancer Preventionl DCP formerly DCPC under extramural contracts to 10 US 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 74000 men and 74000 women aged 55-74 years have been randomized on a 5050 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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH97-C-N041 | None | None | None |