Early Detection of Ovarian Cancer in Low-Risk Women

This study aims to improve early detection of ovarian cancer in women aged 50-74 who are past menopause and have no history of cancer treatment in the last year. Researchers are investigating if combining the standard CA-125 blood test with other blood tests for tumor markers (substances in the blood that may be related to cancer) can better identify ovarian cancer early. The study will enroll up to 8,000 women. Success will be measured by how well the combination of these blood tests can detect increases in tumor marker levels over time, leading to recommendations for further testing like additional blood draws or an ultrasound. The current status of this study is unclear.

Study design
This is an interventional study involving up to 8,000 women. It is designed to see if a combination of blood tests can help detect ovarian cancer earlier.
What's involved
You would have blood drawn for testing and complete questionnaires about your medical history and symptoms. Depending on your test results, you might have follow-up blood tests in 3 months or 1 year, or a blood test and a transvaginal ultrasound (an imaging test of your ovaries) in 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Follow-up blood tests are recommended based on initial results, either in 3 months, 1 year, or 6 weeks along with an ultrasound.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00539162

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

Recruiting
NAAges 50–74InterventionalScreening
M.D. Anderson Cancer Center
~8,000 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Questionnaire

At a glance

Recruiting sites
10 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of increase in CA 125 levels and other tumor markers over time
Measured over 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.
Ovarian Cancer
12 sites across 8 states
Texas5
Florida1
Iowa1
Minnesota1
New Jersey1
New York1
Oklahoma1
Rhode Island1
  • Denise Nebgen, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • Rate of increase in CA 125 levels and other tumor markers over timeBased 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.

    \[Time Frame: Based on CA-125 level and other tumor markers, 3 options will result: 1) re-draw blood (CA-125 and other tumor markers) in 1 year, 2) re-draw blood (CA-125 and other tumor markers) in 3 months, or 3) re-draw blood (CA-125 and other tumor markers) and TVUS in 6 weeks +/- 2 weeks.\]