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

NCT01696994 | Active Not Recruiting Results

• 5 other identifiers: NCI-2012-01758CDR0000078532NCI-P93-0050PLCO-1PLCO-Ovarian
• Study Type: interventional
• Target: 78,216
• Locations: 1 country
• Sites: 1

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).

Conditions

Ovarian Carcinoma; Ovarian Germ Cell Tumor

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.

• Death Rates From All Causes

  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)

  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).

  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

  One year from screening examination

Study Arms (2)

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.

Other: Laboratory Biomarker Analysis; Other: Screening Questionnaire Administration; Procedure: Ultrasound Imaging

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Ovarian Screening

Screening Questionnaire Administration OTHER

Undergo questionnaire assessments

Ovarian Screening

Ultrasound Imaging PROCEDURE

Undergo TVU

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

Ovarian Screening

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: Paul F. Pinsky, Ph.D.
• Organization: Early Detection Research Group, NCI, NIH

pinskyp@mail.nih.gov

301-496-8544

Study Officials

• Christine D Berg

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: November 16, 1993
• Primary Completion: May 21, 2012
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 29, 2026
• Results First Posted: December 12, 2014

Record last verified: 2026-01

Locations

US (1)