NCT04473833Recruiting
Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 14 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 65000 (estimated)
- First submitted
- 13 Jul 2020
- Start date
- 19 Dec 1988
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- John R van Nagell
- Diseases
- Ovarian cancer
- NCT number
- NCT04473833
What you commit to
- Study type: Interventional
- Planned participants: 65000
- From 19 Dec 1988 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women who are referred with pelvic symptoms, a known pelvic mass or a history of prior radiation.
- Women with a prior history of ovarian cancer
Other illness
- 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
Other
- Prisoners
- Pregnant women
- 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
Who the study is looking for
- 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.
Age in the registry: 24 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.