Actively Recruiting

Phase Not Applicable
Age: 24Years +
FEMALE
Healthy Volunteers
NCT04473833

Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

Led by John R van Nagell · Updated on 2025-11-14

65000

Participants Needed

1

Research Sites

1984 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

Who Can Participate

Age: 24Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women over the age of 50 years
  • Women over the age of 24 years with a documented family history of ovarian cancer
  • Women over the age of 24 years with a personal history of breast cancer
  • ECOG performance status between 0 and 2.34
  • Women who have had a hysterectomy but have at least one ovary
  • Ability to understand and willingly sign informed consent
Not Eligible

You will not qualify if you...

  • Women referred with pelvic symptoms, known pelvic mass, or prior radiation history
  • Individuals unable to safely undergo transvaginal ultrasound due to vaginal size, infections, lack of bowel or bladder control, or inability to position themselves
  • Prisoners
  • Pregnant women
  • Women with prior ovarian cancer
  • Anyone unable to understand study procedures, provide informed consent, or provide required personal information

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Markey Cancer Center

Lexington, Kentucky, United States, 40536

Actively Recruiting

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Research Team

E

Edward J Pavlik, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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