- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01696994
Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial)
Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
Participants receive standard medical care.
Participants complete a DHQ at baseline.
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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.
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Correlative studies
Undergo questionnaire assessments
Undergo TVU
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
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Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
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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.
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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.
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Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
Time Frame: One year from screening examination
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Number of positive screens with complications
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One year from screening examination
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Deaths From All Causes
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
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Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.
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Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
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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.
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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.
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Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
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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.
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Ovarian cancer diagnoses confirmed by medical record abstraction.
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Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
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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.
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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.
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Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
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T0 (Baseline) CA-125 Screening Results
Time Frame: T0 (at study entry)
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Cancer Antigen 125 (CA-125) result.
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T0 (at study entry)
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T0 (Baseline) TVU Screening Results
Time Frame: T0 (at study entry)
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Transvaginal Ultrasound (TVU) result.
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T0 (at study entry)
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T1 CA-125 Screening Results
Time Frame: T1 (one year after entry)
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Cancer Antigen 125 (CA-125) result.
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T1 (one year after entry)
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T1 TVU Screening Results
Time Frame: T1 (one year after entry)
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Transvaginal Ultrasound (TVU) result.
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T1 (one year after entry)
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T2 CA-125 Screening Results
Time Frame: T2 (two years after entry)
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Cancer Antigen 125 (CA-125) result.
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T2 (two years after entry)
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T2 TVU Screening Results
Time Frame: T2 (one year after entry)
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Transvaginal Ultrasound (TVU) result.
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T2 (one year after entry)
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T3 CA-125 Screening Results
Time Frame: T3 (three years after entry)
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Cancer Antigen 125 (CA-125) result.
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T3 (three years after entry)
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T3 TVU Screening Results
Time Frame: T3 (three years after entry)
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Transvaginal Ultrasound (TVU) result.
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T3 (three years after entry)
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T4 CA-125 Screening Results
Time Frame: T4 (four years after entry)
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Cancer Antigen 125 (CA-125) result.
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T4 (four years after entry)
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T5 CA-125 Screening Results
Time Frame: T5 (five years after entry)
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Cancer Antigen 125 (CA-125) result.
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T5 (five years after entry)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine D Berg, National Cancer Institute (NCI)
Publications and helpful links
General Publications
- Jiang Y, Xie Q, Chen R. Breast Cancer Incidence and Mortality in Relation to Hormone Replacement Therapy Use Among Postmenopausal Women: Results From a Prospective Cohort Study. Clin Breast Cancer. 2022 Feb;22(2):e206-e213. doi: 10.1016/j.clbc.2021.06.010. Epub 2021 Jun 26.
- Wang K, Wu Q, Li Z, Reger MK, Xiong Y, Zhong G, Li Q, Zhang X, Li H, Foukakis T, Xiang T, Zhang J, Ren G. Vitamin K intake and breast cancer incidence and death: results from a prospective cohort study. Clin Nutr. 2021 May;40(5):3370-3378. doi: 10.1016/j.clnu.2020.11.009. Epub 2020 Nov 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-01758 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000078532
- NCI-P93-0050
- PLCO-1
- PLCO-Ovarian (Other Identifier: National Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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