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Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

Who can join

Ages 24 and older · Women · Healthy volunteers welcome

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

About the study

This is a large, prospective, single-arm cohort study of transvaginal ultrasonographic screening for ovarian cancer in intermediate to high-risk women from Kentucky. Detection of ovarian malignancy often occurs subsequent to the initial transvaginal sonography (TVS) screen; therefore, it is important to offer continued screening to study participants based on our published algorithm. Screening will be available to participants for as long as they elect to receive it. The primary study endpoints are to determine if prospective serial transvaginal ultrasonography can decrease the false-positive (FP) percentage and improve the positive predictive value (PPV) as suggested by retrospective analysis without compromising the detection of true positives or promote the occurrence of false negatives.

What is being tested

• Serial Transvaginal Ultrasonography (procedure)

Sponsor: John R van Nagell · Participants: 65,000 · Started: Dec 19, 1988

Contact the study team

• Edward J Pavlik, PhD · Phone: 859-323-3830

Official record on ClinicalTrials.gov — NCT04473833

Locations in the U.S.

Conditions

• Ovarian Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.