Back to search results

Transvaginal Ultrasonography for Ovarian Cancer Screening

This study is testing if regular transvaginal ultrasonography (TVS) can be an effective way to screen for ovarian cancer in women who are at intermediate to high risk. You might be able to join if you are a woman over 50, or over 24 with a family history of ovarian cancer or a personal history of breast cancer, and have a good general health status (ECOG performance status of 0 to 2). The study aims to see if this screening method can reduce the number of false-positive results (when a test suggests cancer but there isn't any) and improve the accuracy of detecting true cancers. The study plans to enroll 65,000 participants and is currently unclear on its recruitment status.

Study design
This is a large study that will follow participants over time, with everyone receiving the same screening method. It is not specified what phase the study is in.
What's involved
You would undergo transvaginal ultrasonography (TVS). If your results are normal, you would repeat the TVS in one year; if abnormal, you would repeat it in 4-6 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for false-positive percentage is measured at approximately 3 years, suggesting follow-up for at least that long.

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

NCT04473833

Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

Recruiting
NAAges 24+InterventionalScreening
John R van Nagell
~65,000 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:Serial Transvaginal Ultrasonography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
False-positive (FP) percentage
Measured over approximately 3 years

Conditions

Ovarian Cancer

Explore related trials

Malignant Ovarian Neoplasm

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • John R Van Nagell, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Edward J Pavlik, PhD
[email protected]
859-323-3830
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

women over the age of 50 years;
women with a documented family history of ovarian cancer over the age of 24 years;
women over the age of 24 years with a personal history of breast cancer
ECOG performance status of 0 to 2.34
Subjects having undergone prior hysterectomy will be eligible provided that they meet the other requirements for entry into this study and have at least one ovary.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Women who are referred with pelvic symptoms, a known pelvic mass or a history of prior radiation.
Individuals that cannot safely receive transvaginal ultrasound due to vaginal size, vaginal infections, lack of bowel or bladder control or inability to physically place their body in position to receive transvaginal ultrasound
Prisoners
Pregnant women
Women with a prior history of ovarian cancer
Exclusions will apply to anyone who presents with factors or issues that prevent them from understanding the screening research procedures or completing the informed consent component or personal information needed for the study

What this trial measures

  • False-positive (FP) percentageapproximately 3 years

    Measure the false-positive (FP) rate generated by the ovarian screening algorithm.