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: October 17, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention
Ovarian Epithelial Cancer
Ovarian Germ Cell Tumor
Other: cytology specimen collection procedure
Procedure: ultrasound imaging
Other: screening questionnaire administration

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 74000
Study Start Date: November 1993
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 sampling
Procedure: ultrasound imaging
Undergo TVU
Other Names:
  • ultrasonography
  • ultrasound
  • ultrasound test
Other: screening questionnaire administration
Undergo questionnaire assessments

Detailed 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.

  Eligibility

Ages Eligible for Study:   55 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696994

Locations
United States, Maryland
Mark O Hatfield-Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Christine Berg Mark O Hatfield-Warren Grant Magnuson Clinical Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01696994     History of Changes
Other Study ID Numbers: NCI-2012-01758, PLCO-Ovarian
Study First Received: September 28, 2012
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Germinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 22, 2014