Recruiting

Transvaginal Ultrasonography

Sponsor:

John R van Nagell

Code:

NCT04473833

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 24+

Healthy Volunteers: Accepted

Interventions

Serial Transvaginal Ultrasonography

Study Details

Brief 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

Ovarian Cancer

Study ID

NCT04473833

Start date

Dec 19, 1988

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 24+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

65000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Edward J Pavlik, PhD

859-323-3830edward.pavlik@uky.edu

Locations

Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Principal Investigator:

John Villano, MD

More Information

Sponsor

John R van Nagell

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • serial
  • transvaginal ultrasonography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John R van Nagell on 2025-11-14.