Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002540
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
1999-11-01
Brief Title:
Screening for Prostate Cancer in Older Patients PLCO Screening Trial
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Prostate Lung Colorectal and Ovarian PLCO Cancer Screening Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
This clinical trial studies whether screening methods used to diagnose cancer of the prostate lung colon rectum or ovaries can reduce deaths from these cancers Screening tests may help doctors find cancer cells early and plan better treatment for prostate cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether screening with digital rectal examination DRE plus serum prostate-specific antigen PSA can reduce mortality from prostate cancer in men aged 55-74 at entry
SECONDARY OBJECTIVES
I To assess screening variables other than mortality for each of the interventions including sensitivity specificity and positive predictive value
II To assess the incidence stage and survival of cancer cases III To investigate the mortality predictive value of biologic andor prognostic characterizations of tumor tissue as intermediate endpoints
IV To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion as well as the early detection of these factors
OUTLINE Participants in the overall PLCO study are stratified by screening center gender and age 55-59 vs 60-64 vs 65-69 vs 70-74 Participants are randomized to 1 of 2 arms control vs screening
ARM I Control Participants receive standard medical care Participants complete a Diet History Questionnaire DHQ at baseline
ARM II Prostate Screening Participants undergo blood sample collection for PSA analysis at baseline and annually for 5 years Serum that is not used in the study will be stored in an NCI biorepository Participants also undergo a DRE at baseline and annually for 3 years A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal prostate cancer follow-up diagnostic procedures are through their own medical care environment Participants diagnosed with prostate cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease patient age and medical condition a procedure is provided for contact with qualified medical personnel to insure appropriate therapy
Participants complete a Dietary Questionnaire DQX at baseline and DHQ at year 3 An Annual Study Update ADU previously referred to as the Periodic Survey of Health PSH questionnaire is mailed to each participant annually for 13 years to identify all prevalent and incident prostate cancers as all deaths that occur among both screened and control subjects during the trial
After completion of screening participants are followed up for at least 13 years
I To determine whether screening with digital rectal examination DRE plus serum prostate-specific antigen PSA can reduce mortality from prostate cancer in men aged 55-74 at entry
SECONDARY OBJECTIVES
I To assess screening variables other than mortality for each of the interventions including sensitivity specificity and positive predictive value
II To assess the incidence stage and survival of cancer cases III To investigate the mortality predictive value of biologic andor prognostic characterizations of tumor tissue as intermediate endpoints
IV To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion as well as the early detection of these factors
OUTLINE Participants in the overall PLCO study are stratified by screening center gender and age 55-59 vs 60-64 vs 65-69 vs 70-74 Participants are randomized to 1 of 2 arms control vs screening
ARM I Control Participants receive standard medical care Participants complete a Diet History Questionnaire DHQ at baseline
ARM II Prostate Screening Participants undergo blood sample collection for PSA analysis at baseline and annually for 5 years Serum that is not used in the study will be stored in an NCI biorepository Participants also undergo a DRE at baseline and annually for 3 years A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal prostate cancer follow-up diagnostic procedures are through their own medical care environment Participants diagnosed with prostate cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease patient age and medical condition a procedure is provided for contact with qualified medical personnel to insure appropriate therapy
Participants complete a Dietary Questionnaire DQX at baseline and DHQ at year 3 An Annual Study Update ADU previously referred to as the Periodic Survey of Health PSH questionnaire is mailed to each participant annually for 13 years to identify all prevalent and incident prostate cancers as all deaths that occur among both screened and control subjects during the trial
After completion of screening participants are followed up for at least 13 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| NCI-2012-01755 | REGISTRY | None | None |
| CDR0000078532 | None | None | None |
| NCI-P93-0050 | None | None | None |
| PLCO-1 | None | None | None |
| PLCO-Prostate | OTHER | National Cancer Institute | None |