Overview

This trial is active, not recruiting.

Conditions ovarian epithelial cancer, ovarian germ cell tumor
Treatments ultrasound imaging, screening questionnaire administration, laboratory biomarker analysis
Sponsor National Cancer Institute (NCI)
Start date November 1993
End date May 2012
Trial size 78216 participants
Trial identifier NCT01696994, CDR0000078532, NCI-2012-01758, NCI-P93-0050, PLCO-1, PLCO-Ovarian

Summary

The ovarian cancer screening tests are part of a trial that addresses the screening of four cancer sites, each with their own results record: prostate (NCT00002540), lung (NCT01696968), colorectal (NCT01696981), and ovarian (NCT01696994).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose screening
Arm
(No Intervention)
Participants receive standard medical care. Participants complete a DHQ at baseline.
(Active Comparator)
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.
ultrasound imaging
Undergo TVU
screening questionnaire administration
Undergo questionnaire assessments
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.

Secondary Outcomes

Measure
Deaths From All Causes
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Death Rates From All Causes
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).
time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
time frame: One year from screening examination
T0 (Baseline) CA-125 Screening Results
time frame: T0 (at study entry)
T0 (Baseline) TVU Screening Results
time frame: T0 (at study entry)
T1 CA-125 Screening Results
time frame: T1 (one year after entry)
T1 TVU Screening Results
time frame: T1 (one year after entry)
T2 CA-125 Screening Results
time frame: T2 (two years after entry)
T2 TVU Screening Results
time frame: T2 (one year after entry)
T3 CA-125 Screening Results
time frame: T3 (three years after entry)
T3 TVU Screening Results
time frame: T3 (three years after entry)
T4 CA-125 Screening Results
time frame: T4 (four years after entry)
T5 CA-125 Screening Results
time frame: T5 (five years after entry)

Eligibility Criteria

Female participants from 55 years up to 74 years old.

Exclusion Criteria (the following criteria are applied to the females in the study, all of whom are also included in the lung and colorectal study outcomes): - Women who at the time of randomization are less than 55 or greater than or equal to 75 years of age - Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer - Individuals with known prior cancer of the colon, rectum, lung, or ovary - This includes primary or metastatic PLCO cancers - Individuals with previous surgical removal of the entire colon or one lung - Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason. - Individuals who are participating in another cancer screening or cancer primary prevention trial - Prior to April 1, 1999 women were excluded from the trial if they were currently taking or had taken Tamoxifen or Evista\Raloxifene in the past 6 months. As of April 1999 based on a decision from the PLCO Ovary Subcommittee, women who have or are currently taking Tamoxifen or Evista\Raloxifene are not excluded from participation. - Individuals who are unwilling or unable to sign the informed consent form - Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years

Additional Information

Official title Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
Principal investigator Christine Berg
Description PRIMARY OBJECTIVES: I. To determine whether screening with CA125 and transvaginal ultrasound (TVU) can reduce mortality from ovarian cancer in women 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 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).