Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial)
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 ovarian cancer
Ovarian Epithelial Cancer
Ovarian Germ Cell Tumor
Other: cytology specimen collection procedure
Procedure: ultrasound imaging
Other: screening questionnaire administration
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
|Official Title:||Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial|
- Ovarian cancer-specific mortality rate (including primary peritoneal and fallopian tube cancers) [ Time Frame: Up to 13 years ] [ Designated as safety issue: Yes ]Event rates defined as the ratio of the number of events (deaths) to the person-years at the risk for the event.
- Ovarian cancer-specific incidence rate (including primary peritoneal and fallopian tube cancers [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]Event rates defined as the ratio of the number of events (diagnosis) to the person-years at the risk for the event.
|Study Start Date:||November 1993|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
No Intervention: Control
Participants receive standard medical care. Participants complete a DHQ at baseline.
Active Comparator: Ovarian Screening
Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident cancers of the ovaries as all deaths that occur among both screened and control subjects during the trial.
Other: cytology specimen collection procedure
Undergo blood sample collection for CA-125 analysis
Other Name: cytologic samplingProcedure: ultrasound imaging
Other Names:Other: screening questionnaire administration
Undergo questionnaire assessments
I. To determine whether screening with CA125 and transvaginal ultrasound (TVU) can reduce mortality from ovarian cancer in women aged 55-74 at entry.
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 and/or 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 (Ovarian Screening): Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo an ovarian palpation exam (OVR, discontinued in December 1998) and TVU 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 ovarian cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with ovarian 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 cancers of the ovaries 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696994
|United States, Maryland|
|Mark O Hatfield-Warren Grant Magnuson Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Christine Berg||Mark O Hatfield-Warren Grant Magnuson Clinical Center|