Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
John R van Nagell
Study ID
NCT04473833
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
24 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Serial Transvaginal Ultrasonography — PROCEDURE
    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.

Study Details

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 Dates

Start date
Dec 19, 1988
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
65,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Participants in the Kentucky Ovarian Cancer Screening Program
    Participants from the Kentucky Ovarian Cancer Screening Program who choose to participate in this trial will undergo further serial transvaginal ultrasonography (TVS) screening.

Primary Outcome Measure

False-positive (FP) percentage [ Time Frame: approximately 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Markey Cancer CenterLexingtonKentucky40536
John R Van Nagell
John Villano, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lexington, KY

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Markey Cancer Center· Lexington, KY

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