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Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
Sponsor: John R van Nagell
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
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