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RECRUITING
NCT04473833
NA

Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

Sponsor: John R van Nagell

View on ClinicalTrials.gov

Summary

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 Details

Gender

FEMALE

Age Range

24 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65000

Start Date

1988-12-19

Completion Date

2026-12-31

Last Updated

2025-11-14

Healthy Volunteers

Yes

Conditions

Interventions

PROCEDURE

Serial Transvaginal Ultrasonography

Participants will undergo transvaginal ultrasonography (TVS) to detect ovarian cancer as part of the Kentucky Ovarian Cancer Screening Program. Those with normal findings will repeat the TVS in one year. Those with abnormal results will repeat the screening in 4-6 weeks.

Locations (1)

Markey Cancer Center

Lexington, Kentucky, United States