Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

Recruiting now · Not applicable

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID: NCT04473833
Run by: John R van Nagell
People needed: 65000
Starts: 1988-12-19
Expected to finish: 2026-12-31
Last updated by the study team: 2025-11-14

Who can join

Age: 24 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Markey Cancer Center — Lexington, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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