Ovarian CarcinomaNCT01696994

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

A study testing Laboratory Biomarker Analysis, Screening Questionnaire Administration and Ultrasound Imaging in people with Ovarian Carcinoma and Ovarian Germ Cell Tumor, run by National Cancer Institute (NCI) at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 55 to 74 years, women only
Conditions the study is for: Ovarian Carcinoma, Ovarian Germ Cell Tumor
What is being tested?: Laboratory Biomarker Analysis, Screening Questionnaire Administration and Ultrasound Imaging
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78,216 participants
Where: 1 siteUnited States
Study dates: 16 Nov 1993to 30 Jun 2027
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 74 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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.

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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).

Read the detailed description

PRIMARY OBJECTIVES:

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:

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.

Conditions: Ovarian Carcinoma, Ovarian Germ Cell Tumor
Being tested: Laboratory Biomarker Analysis, Screening Questionnaire Administration, Ultrasound Imaging
Medical subject headings: Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laboratory Biomarker AnalysisOther
Correlative studies
Screening Questionnaire AdministrationOther
Undergo questionnaire assessments
Ultrasound ImagingProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography
Undergo TVU

Study groups in NCT01696994
Study group	Role	What they receive
Control	No intervention	Participants receive standard medical care. Participants complete a DHQ at baseline.
Ovarian Screening	Active comparator	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. Receives: Other: Laboratory Biomarker Analysis; Other: Screening Questionnaire Administration; Procedure: Ultrasound Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)
Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)
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.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.

Secondary outcomes (15)

Deaths From All Causes
Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Death Rates From All Causes
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.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)
Ovarian cancer diagnoses confirmed by medical record abstraction.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).
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.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
Number of positive screens with complications
Measured: One year from screening examination
T0 (Baseline) CA-125 Screening Results
Cancer Antigen 125 (CA-125) result.
Measured: T0 (at study entry)
T0 (Baseline) TVU Screening Results
Transvaginal Ultrasound (TVU) result.
Measured: T0 (at study entry)
T1 CA-125 Screening Results
Cancer Antigen 125 (CA-125) result.
Measured: T1 (one year after entry)
T1 TVU Screening Results
Transvaginal Ultrasound (TVU) result.
Measured: T1 (one year after entry)
T2 CA-125 Screening Results
Cancer Antigen 125 (CA-125) result.
Measured: T2 (two years after entry)
T2 TVU Screening Results
Transvaginal Ultrasound (TVU) result.
Measured: T2 (one year after entry)
T3 CA-125 Screening Results
Cancer Antigen 125 (CA-125) result.
Measured: T3 (three years after entry)
T3 TVU Screening Results
Transvaginal Ultrasound (TVU) result.
Measured: T3 (three years after entry)
T4 CA-125 Screening Results
Cancer Antigen 125 (CA-125) result.
Measured: T4 (four years after entry)
T5 CA-125 Screening Results
Cancer Antigen 125 (CA-125) result.
Measured: T5 (five years after entry)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 199330 Jun 2027

First posted2 Oct 2012 (estimated)
Study start16 Nov 1993
Primary completion21 May 2012
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 78,216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01696994
Sponsor's protocol ID: NCI-2012-01758
Other IDs: NCI-2012-01758, CDR0000078532, NCI-P93-0050, PLCO-1, PLCO-Ovarian
Status last verified: Jul 2026
First submitted: 28 Sep 2012
Last updated: 24 Jul 2026
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 41261199
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.
PubMed 38741776
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.
PubMed 34548240
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.
PubMed 33277073

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
ClinicalTrials.gov ID: NCT01696994
Acronym / sponsor ID: NCI-2012-01758
Conditions: Ovarian Carcinoma, Ovarian Germ Cell Tumor
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 78,216 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 16 Nov 1993 (actual)
Primary completion: 21 May 2012 (actual)
Study completion: 30 Jun 2027 (estimated)
First posted: 2 Oct 2012 (estimated)
Results: Posted 12 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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:

To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value.

IV. To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion, as well as the early detection of these factors.

ARM I (Control): Participants receive standard medical care. Participants complete a Diet History Questionnaire (DHQ) at baseline.

After completion of screening, participants are followed up for at least 13 years.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Participants receive standard medical care. Participants complete a DHQ at baseline.
Ovarian Screening	Active comparator	Other: Laboratory Biomarker Analysis, Other: Screening Questionnaire Administration, Procedure: Ultrasound ImagingParticipants 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.

Who may qualify

Ages: 55 to 74 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (10 listed)

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
Individuals with previous surgical removal of the entire colon or one lung
Individuals who are participating in another cancer screening or cancer primary prevention trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laboratory Biomarker AnalysisCorrelative studies	Other	Ovarian Screening
Screening Questionnaire AdministrationUndergo questionnaire assessments	Other	Ovarian Screening
Ultrasound ImagingAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasonographyUndergo TVU	Procedure or surgery	Ovarian Screening

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.

15 secondary outcomes

Deaths From All Causes
Time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
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.
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 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.
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
Time frame: One year from screening examination
T0 (Baseline) CA-125 Screening Results
Time frame: T0 (at study entry)
T0 (Baseline) TVU Screening Results
Time frame: T0 (at study entry)
T1 CA-125 Screening Results
Time frame: T1 (one year after entry)
T1 TVU Screening Results
Time frame: T1 (one year after entry)
T2 CA-125 Screening Results
Time frame: T2 (two years after entry)
T2 TVU Screening Results
Time frame: T2 (one year after entry)
T3 CA-125 Screening Results
Time frame: T3 (three years after entry)
T3 TVU Screening Results
Time frame: T3 (three years after entry)
T4 CA-125 Screening Results
Time frame: T4 (four years after entry)
T5 CA-125 Screening Results
Time frame: T5 (five years after entry)

Results and safety

Results posted to the registry on 12 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	39,111	33,919
Ovarian Screening	39,105	30,668

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.. Number. Unit: Participants

Measure	Control n = 34304	Ovarian Screening n = 34253
Value	100	188

Primary outcome: 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.. Number. Unit: Deaths per 10,000 PY

Measure	Control n = 34304	Ovarian Screening n = 34253
Value	2.6	3.1

Control vs Ovarian Screening: Hazard Ratio (HR): 1.18 (95% CI .91 to 1.54), Poisson regression

Population analysed: Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: During each annual screening visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ovarian Screening	0 of 34,253 (0%)	903 of 34,253 (2.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41261199Malcomson 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.
Derived from this study: PubMed 38741776Fan 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.
Derived from this study: PubMed 34548240Jiang 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.
Derived from this study: PubMed 33277073Wang 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.

Related trials for Ovarian Carcinoma

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine D Berg principal investigator

National Cancer Institute (NCI)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01696994, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.