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Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

NCT04473833 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65000

Last updated 2025-11-14

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • John R van Nagell

    lead OTHER

Principal Investigators

  • John R Van Nagell, MD · University of Kentucky

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1988-12-19
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04473833 on ClinicalTrials.gov