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Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

John R van Nagell · NCT04473833

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 24+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
65000
US sites recruiting
1
Study start
December 19, 1988
Record last updated
November 14, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Serial Transvaginal Ultrasonography

Conditions: Ovarian Cancer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • women over the age of 50 years;
  • women with a documented family history of ovarian cancer over the age of 24 years;
  • women over the age of 24 years with a personal history of breast cancer
  • ECOG performance status of 0 to 2.34
  • Subjects having undergone prior hysterectomy will be eligible provided that they meet the other requirements for entry into this study and have at least one ovary.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • Women who are referred with pelvic symptoms, a known pelvic mass or a history of prior radiation.
  • Individuals that cannot safely receive transvaginal ultrasound due to vaginal size, vaginal infections, lack of bowel or bladder control or inability to physically place their body in position to receive transvaginal ultrasound
  • Prisoners
  • Pregnant women
  • Women with a prior history of ovarian cancer
  • Exclusions will apply to anyone who presents with factors or issues that prevent them from understanding the screening research procedures or completing the informed consent component or personal information needed for the study

Recruiting US locations

  • Markey Cancer Center

    Lexington, KY 40536

    Site contact: John R Van Nagell

Study contacts (from the official record)

  • Edward J Pavlik, PhD · 859-323-3830 · edward.pavlik@uky.edu
All healthy volunteers studies in Kentucky →
Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer (NCT04473833) | Bored Studies