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NCT01696994 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-07-24

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)

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outcome · POSTED

Deaths From All Causes

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outcome · POSTED

Death Rates From All Causes

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outcome · POSTED

Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)

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outcome · POSTED

Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).

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outcome · POSTED

Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test

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outcome · POSTED

T0 (Baseline) CA-125 Screening Results

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outcome · POSTED

T0 (Baseline) TVU Screening Results

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outcome · POSTED

T1 CA-125 Screening Results

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outcome · POSTED

T1 TVU Screening Results

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outcome · POSTED

T2 CA-125 Screening Results

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outcome · POSTED

T2 TVU Screening Results

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outcome · POSTED

T3 CA-125 Screening Results

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outcome · POSTED

T3 TVU Screening Results

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outcome · POSTED

Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)

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outcome · POSTED

T4 CA-125 Screening Results

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outcome · POSTED

T5 CA-125 Screening Results

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
74 Years
minimum Age
55 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants receive standard medical care. Participants complete a DHQ at baseline.
    label
    Control
    type
    NO_INTERVENTION
  2. description
    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.
    intervention Names
    1. Other: Laboratory Biomarker Analysis
    2. Other: Screening Questionnaire Administration
    3. Procedure: Ultrasound Imaging
    label
    Ovarian Screening
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Ovarian Screening
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  2. arm Group Labels
    1. Ovarian Screening
    description
    Undergo questionnaire assessments
    name
    Screening Questionnaire Administration
    type
    OTHER
  3. arm Group Labels
    1. Ovarian Screening
    description
    Undergo TVU
    name
    Ultrasound Imaging
    other Names
    1. 2-Dimensional Grayscale Ultrasound Imaging
    2. 2-Dimensional Ultrasound Imaging
    3. 2D-US
    4. Ultrasonography
    5. Ultrasound
    6. Ultrasound Test
    7. Ultrasound, Medical
    8. US
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
SINGLE
who Masked
  1. INVESTIGATOR
primary Purpose
SCREENING
Enrollment
count
78216
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
    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.
  2. description
    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.
    measure
    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
  1. description
    Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.
    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.
  2. description
    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.
    measure
    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.
  3. description
    Ovarian cancer diagnoses confirmed by medical record abstraction.
    measure
    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.
  4. description
    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.
    measure
    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.
  5. description
    Number of positive screens with complications
    measure
    Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
    time Frame
    One year from screening examination
  6. description
    Cancer Antigen 125 (CA-125) result.
    measure
    T0 (Baseline) CA-125 Screening Results
    time Frame
    T0 (at study entry)
  7. description
    Transvaginal Ultrasound (TVU) result.
    measure
    T0 (Baseline) TVU Screening Results
    time Frame
    T0 (at study entry)
  8. description
    Cancer Antigen 125 (CA-125) result.
    measure
    T1 CA-125 Screening Results
    time Frame
    T1 (one year after entry)
  9. description
    Transvaginal Ultrasound (TVU) result.
    measure
    T1 TVU Screening Results
    time Frame
    T1 (one year after entry)
  10. description
    Cancer Antigen 125 (CA-125) result.
    measure
    T2 CA-125 Screening Results
    time Frame
    T2 (two years after entry)
  11. description
    Transvaginal Ultrasound (TVU) result.
    measure
    T2 TVU Screening Results
    time Frame
    T2 (one year after entry)
  12. description
    Cancer Antigen 125 (CA-125) result.
    measure
    T3 CA-125 Screening Results
    time Frame
    T3 (three years after entry)
Full study description
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 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.
Source references
references
  1. citation
    Malcomson FC, Shams-White MM, Reedy J, Huang WY, Moore SC, Loftfield E. Adherence to the 2018 World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Recommendations and risk of lifestyle-related cancers in the prostate, lung, colorectal, and ovarian cancer screening trial. BJC Rep. 2025 Nov 19;3(1):81. doi: 10.1038/s44276-025-00195-6.
    pmid
    41261199
    type
    DERIVED
  2. citation
    Fan Z, Zhang Y, Yao Q, Liu X, Duan H, Liu Y, Sheng C, Lyu Z, Yang L, Song F, Huang Y, Song F. Effects of joint screening for prostate, lung, colorectal, and ovarian cancer - results from a controlled trial. Front Oncol. 2024 Apr 29;14:1322044. doi: 10.3389/fonc.2024.1322044. eCollection 2024.
    pmid
    38741776
    type
    DERIVED
  3. citation
    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.
    pmid
    34548240
    type
    DERIVED
  4. citation
    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.
    pmid
    33277073
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice