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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

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 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).

Detailed Summary:

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 s
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • 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 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. ]
    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.


Original Primary Outcome: Ovarian cancer-specific mortality rate (including primary peritoneal and fallopian tube cancers) [ Time Frame: Up to 13 years ]

Event rates defined as the ratio of the number of events (deaths) to the person-years at the risk for the event.


Current Secondary Outcome:

  • Deaths From All Causes [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]
    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. ]
    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. ]
    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. ]
    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 ]
    Number of positive screens with complications
  • T0 (Baseline) CA-125 Screening Results [ Time Frame: T0 (at study entry) ]
    Cancer Antigen 125 (CA-125) result.
  • T0 (Baseline) TVU Screening Results [ Time Frame: T0 (at study entry) ]
    Transvaginal Ultrasound (TVU) result.
  • T1 CA-125 Screening Results [ Time Frame: T1 (one year after entry) ]
    Cancer Antigen 125 (CA-125) result.
  • T1 TVU Screening Results [ Time Frame: T1 (one year after entry) ]
    Transvaginal Ultrasound (TVU) result.
  • T2 CA-125 Screening Results [ Time Frame: T2 (two years after entry) ]
    Cancer Antigen 125 (CA-125) result.
  • T2 TVU Screening Results [ Time Frame: T2 (one year after entry) ]
    Transvaginal Ultrasound (TVU) result.
  • T3 CA-125 Screening Results [ Time Frame: T3 (three years after entry) ]
    Cancer Antigen 125 (CA-125) result.
  • T3 TVU Screening Results [ Time Frame: T3 (three years after entry) ]
    Transvaginal Ultrasound (TVU) result.
  • T4 CA-125 Screening Results [ Time Frame: T4 (four years after entry) ]
    Cancer Antigen 125 (CA-125) result.
  • T5 CA-125 Screening Results [ Time Frame: T5 (five years after entry) ]
    Cancer Antigen 125 (CA-125) result.


Original Secondary Outcome: Ovarian cancer-specific incidence rate (including primary peritoneal and fallopian tube cancers [ Time Frame: Up to 13 years ]

Event rates defined as the ratio of the number of events (diagnosis) to the person-years at the risk for the event.


Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 28, 2012
Date Started: November 1993
Date Completion:
Last Updated: December 28, 2016
Last Verified: December 2016