Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women

May 1, 2026 updated by: M.D. Anderson Cancer Center
The goal of this clinical research study is to find out if combining a standard blood test (CA-125) that checks for ovarian cancer with other blood tests that check for related tumor markers may be helpful in the early detection of ovarian cancer in women who are at low risk. Tumor markers are substances in the blood that may be related to ovarian cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Up to 8,000 women will take part in this multicenter study.

Currently, there is no effective screening to detect ovarian cancer at its earliest stage in low risk women. CA-125 is an FDA approved blood test that may show the presence of ovarian cancer. Researchers have found other blood tests that detect ovarian cancers that may be missed by CA125 testing. Results of blood tests are combined into a Risk of Ovarian Cancer-2 (ROCA2) score to decide whether you need to return for additional bloodwork and/or an ultrasound.

If you are eligible to take part in this research study:

You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers that can detect ovarian cancer.

You will be asked to complete a questionnaire about your medical and family history. It should take about 20-30 minutes to complete.

You will be asked to complete a questionnaire about your symptoms. It should take about 10-15 minutes to complete.

Depending on your CA-125 level you will receive 1 of 3 recommendations:

You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers in 1 year.

You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers in 3 months, OR You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers, and you will have a transvaginal ultrasound (to look at your ovaries and fallopian tubes) in 6 weeks +/- 2 weeks.

An ultrasound test uses sound waves to check the position, size, and shape of the ovaries. During a transvaginal ultrasound, a small probe will be placed in your vagina and used to create and measure sound waves.

Based on the results of the transvaginal ultrasound (if you receive one):

You and the study doctor will discuss options for further treatment or standard cancer management, OR You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers in 3 months.

When you return for your next yearly visit:

You will be asked to complete the questionnaire about your symptoms. You will be asked to complete a follow-up visit survey so that any updates to your personal and family medical history can be recorded. It should take about 10 minutes to complete.

Your blood draw results will be sent to you by letter or e-mail so that you will know when to return for a visit.

If you miss a visit, the study staff may try to contact you by telephone, e-mail, or letter. Visit reminders may also be sent to you by letter or e-mail.

If you are unable to return for visits after 3 years, you will be taken off study. You may continue to take part in this study unless you no longer qualify for the study or you no longer would like to take part in this study.

If you develop ovarian or non-ovarian cancer on this study, researchers will no longer collect blood draws, transvaginal ultrasounds, or questionnaires from you. However, the study team will continue to collect updates in your medical record. This includes slides that will be reviewed from cases of ovarian or non-ovarian cancer that are collected as part of your standard of care.

Study Type

Interventional

Enrollment (Estimated)

8000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Study Coordinator MD Anderson
  • Phone Number: 713-563-6728

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine
        • Principal Investigator:
          • Brian Slomovitz, MD
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • John Stoddard Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota
        • Contact:
          • Samantha Hoffman, MD
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Recruiting
        • Carol G. Simon Cancer Center / Atlantic Health
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
          • Richard Moore, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
          • Laura Holman, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women's and Infant's Hospital
    • Texas
      • Austin, Texas, United States, 78712
        • Active, not recruiting
        • The University of Texas at Austin
      • Dallas, Texas, United States, 75390
        • Active, not recruiting
        • University of Texas (UT) Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Denise H. Nebgen, MD, PHD, MD, PHD
      • Houston, Texas, United States, 77054
        • Recruiting
        • Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health Science Center San Antonio
        • Contact:
          • Georgia McCann, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female, >/= 50 years old or less than 75 years old.
  2. Postmenopausal (>/= 12 months amenorrhea).
  3. Have at least one ovary.
  4. Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study.
  5. Willingness to return for CA 125 blood tests annually or earlier if indicated.
  6. Willingness to return to undergo transvaginal ultrasound if indicated.
  7. Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated

Exclusion Criteria:

  1. Female: Less than 50 years old or older than 75 years at the time of enrollment.
  2. Psychiatric or psychological or other conditions which prevent a fully informed consent.
  3. Prior removal of both ovaries.
  4. Active non-ovarian malignancy.
  5. Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months. If they are on SERMS (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment <12 months prior to study entry for basal cell carcinoma only.
  6. High risk for ovarian cancer due to familial predisposition as defined by the following: a. Known mutation in BRCA1 of BRCA2. b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer & one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal & one post-menopausal breast cancer. (These conditions can also be met using the patient and one 1st or 2nd degree female relative.) c. Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer. d. 1st or 2nd degree male relative with breast cancer diagnosed at any age. (First degree relative defined as children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.)
  7. Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CA 125 Analysis

Experimental: CA-125 Analysis

Experimental: CA-125, HE4, and Osteopontin bio-marker analysis. Participants will have blood (3-4 tablespoons) drawn for CA-125 and other tumor markers.

Depending on CA-125 level and other tumor markers:

Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year.

Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR

Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks.
Behavioral: Questionnaire
Questionnaires completed at baseline and during each follow up visit.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of increase in CA 125 levels and other tumor markers over time
Time Frame: Based on CA-125 level, 3 options will result: 1) re-draw blood (CA-125) in 1 year, 2) re-draw blood (CA-125) in 3 months), or 3) re-draw blood (CA-125) AND TVUS in 6 weeks +/- 2 weeks.
[Time Frame: Based on CA-125 level and other tumor markers, 3 options will result: 1) re-draw blood (CA-125 and other tumor markers) in 1 year, 2) re-draw blood (CA-125 and other tumor markers) in 3 months, or 3) re-draw blood (CA-125 and other tumor markers) and TVUS in 6 weeks +/- 2 weeks.]
Based on CA-125 level, 3 options will result: 1) re-draw blood (CA-125) in 1 year, 2) re-draw blood (CA-125) in 3 months), or 3) re-draw blood (CA-125) AND TVUS in 6 weeks +/- 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)
Golfers Against Cancer

Investigators

  • Principal Investigator: Denise Nebgen, MD, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2001

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

October 3, 2007

First Submitted That Met QC Criteria

October 3, 2007

First Posted (Estimated)

October 4, 2007

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID01-022
  • P50CA083639 (U.S. NIH Grant/Contract)
  • RP160145 (Other Grant/Funding Number: CPRIT)
  • U01CA200462 (U.S. NIH Grant/Contract)
  • NCI-2018-02168 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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