Can a simple ultrasound catch ovarian cancer early?
NCT ID NCT04473833
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study is testing whether yearly transvaginal ultrasounds can improve ovarian cancer screening in women at intermediate to high risk. Researchers aim to reduce false alarms while still catching real cancers. Up to 65,000 women in Kentucky will be screened over time to see if this approach works better than current methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transvaginal ultrasonography (TVS)
- What this could lead to
- If successful, this could make ovarian cancer screening more accurate, catching cancers earlier and reducing unnecessary surgeries from false alarms.
- What could go wrong
- This is a screening study, not a treatment trial. It may not reduce deaths from ovarian cancer, and false positives could still cause anxiety or unnecessary procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 65,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 1988
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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24 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Markey Cancer Center
RECRUITINGLexington, Kentucky, 40536, United States
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