Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01696994
First received: September 28, 2012
Last updated: July 5, 2016
Last verified: July 2016

September 28, 2012
July 5, 2016
November 1993
May 2012   (final data collection date for primary outcome 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. ] [ Designated as safety issue: No ]
    Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
  • 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. ] [ Designated as safety issue: No ]
    Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
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.
Complete list of historical versions of study NCT01696994 on ClinicalTrials.gov Archive Site
  • Deaths From All Causes [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ] [ Designated as safety issue: No ]
    Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.
  • 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. ] [ Designated as safety issue: No ]
    Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.
  • 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. ] [ Designated as safety issue: No ]
    Ovarian cancer diagnoses confirmed by medical record abstraction.
  • 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. ] [ Designated as safety issue: No ]
    Ovarian cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as ovarian cancer diagnoses divided by person years at risk for ovarian cancer.
  • Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test [ Time Frame: One year from screening examination ] [ Designated as safety issue: Yes ]
    Number of positive screens with complications
  • T0 (Baseline) CA-125 Screening Results [ Time Frame: T0 (at study entry) ] [ Designated as safety issue: No ]
    Cancer Antigen 125 (CA-125) result.
  • T0 (Baseline) TVU Screening Results [ Time Frame: T0 (at study entry) ] [ Designated as safety issue: No ]
    Transvaginal Ultrasound (TVU) result.
  • T1 CA-125 Screening Results [ Time Frame: T1 (one year after entry) ] [ Designated as safety issue: No ]
    Cancer Antigen 125 (CA-125) result.
  • T1 TVU Screening Results [ Time Frame: T1 (one year after entry) ] [ Designated as safety issue: No ]
    Transvaginal Ultrasound (TVU) result.
  • T2 CA-125 Screening Results [ Time Frame: T2 (two years after entry) ] [ Designated as safety issue: No ]
    Cancer Antigen 125 (CA-125) result.
  • T2 TVU Screening Results [ Time Frame: T2 (one year after entry) ] [ Designated as safety issue: No ]
    Transvaginal Ultrasound (TVU) result.
  • T3 CA-125 Screening Results [ Time Frame: T3 (three years after entry) ] [ Designated as safety issue: No ]
    Cancer Antigen 125 (CA-125) result.
  • T3 TVU Screening Results [ Time Frame: T3 (three years after entry) ] [ Designated as safety issue: No ]
    Transvaginal Ultrasound (TVU) result.
  • T4 CA-125 Screening Results [ Time Frame: T4 (four years after entry) ] [ Designated as safety issue: No ]
    Cancer Antigen 125 (CA-125) result.
  • T5 CA-125 Screening Results [ Time Frame: T5 (five years after entry) ] [ Designated as safety issue: No ]
    Cancer Antigen 125 (CA-125) result.
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.
Not Provided
Not Provided
 
Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial)
Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer 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. 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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
  • Ovarian Carcinoma
  • Ovarian Germ Cell Tumor
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Screening Questionnaire Administration
    Undergo questionnaire assessments
  • Procedure: Ultrasonography
    Undergo TVU
    Other Names:
    • ULTRASOUND
    • Ultrasound Imaging
    • Ultrasound Test
    • Ultrasound, Medical
    • US
  • 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.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Other: Screening Questionnaire Administration
    • Procedure: Ultrasonography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
78216
Not Provided
May 2012   (final data collection date for primary outcome measure)

Exclusion Criteria:

  • 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
Female
55 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01696994
NCI-2012-01758, NCI-2012-01758, PLCO-1, CDR0000078532, NCI-P93-0050, PLCO-Ovarian
Not Provided
Not Provided
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Christine Berg National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP