Ovarian CancerNCT04473833
Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
A study testing Serial Transvaginal Ultrasonography in people with Ovarian Cancer, run by John R van Nagell at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Serial Transvaginal Ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65,000 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 1988to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Markey Cancer Center
Lexington, Kentucky, 40536
John R Van Nagell
John Villano, MD
About this study
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.
Read the detailed description
Women from every Kentucky county participate in the Kentucky Ovarian Cancer Screening Program. Screening sites include: Maysville, Prestonsburg, Greenup, Elizabethtown, Somerset, Paducah and Lexington. Offsite participants account for 14% of the screening population with 86% being screened in Lexington. The long-term survival (20 year) of women with screen-detected ovarian cancers is twice that of unscreened women (65% vs 32%). Separation of cases into Type 1 and Type 2 ovarian cancer shows that screening improves the survival of both Type 1 and Type 2 ovarian cancers. Type 1 ovarian carcinomas for the screened and unscreened populations were defined based on these WHO criteria: mucinous carcinomas all grade, clear cell carcinomas all grades, endometrioid carcinomas grades 1 \& 2, serous carcinomas grades 1 \& 2, and malignant Brenner's tumors all grades. Type 2 ovarian carcinomas for the screened and unscreened populations were defined based on these criteria: undifferentiated carcinomas, endometrioid carcinomas grade 3, serous carcinomas grade 3, and carcinosarcomas.
While long-term 20-year survival of women with Type 1 ovarian cancers detected by screening was significantly better than for unscreened women (81% v 46%, respectively), the survival benefit was even more pronounced for Type 2 ovarian cancers detected by screening of Kentucky women compared to unscreened Kentucky women (55.7% vs. 0.3%, respectively) or unscreened women at UK Hospital (12%). Screen-detected cases of Type 2 invasive ovarian cancers had better survival than unscreened cases when those detected had early- or late-stage disease. However, better survival was achieved when Type 2 ovarian cancers were detected at an early (72%) compared to late-stage (46%). Our data support the effectiveness of the screening protocol at the University of Kentucky, and subsequent treatment in accordance with National Comprehensive Cancer Network guidelines.
The significance of these findings is that our approach has resulted in the detection of both early-stage Type 1 and Type 2 ovarian cancers and these cases have had improved survival when compared to that of unscreened cases, indicating that the screen-detected cases are associated with a potential survival advantage even for aggressive ovarian carcinomas.
The primary objective of this study is to prospectively evaluate the false positive (FP) percentage generated by the ovarian screening algorithm and determine whether serial transvaginal ultrasonography can lower the FP percentage as demonstrated in the retrospective analysis. The aim of serial ultrasonography is to decrease FP percentage to 0.32% (positive predictive value of 24%) without adversely impacting the results for true positives and false negatives. on a "per woman screened basis" since this corresponds to a minimally acceptable positive predictive value of 24% or higher. This assumes an average of three screening years for each new woman entering the program.
- Conditions
- Ovarian Cancer
- Being tested
- Serial Transvaginal Ultrasonography
- Keywords
- serial, transvaginal ultrasonography
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial Transvaginal UltrasonographyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants in the Kentucky Ovarian Cancer Screening Program | Experimental | Participants from the Kentucky Ovarian Cancer Screening Program who choose to participate in this trial will undergo further serial transvaginal ultrasonography (TVS) screening. Receives: Procedure: Serial Transvaginal Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
False-positive (FP) percentage
Measure the false-positive (FP) rate generated by the ovarian screening algorithm.
Measured: approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start19 Dec 1988
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John R van Nagell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John R van Nagell, University of Kentucky
- Investigators
- John R Van Nagell, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473833
- Sponsor's protocol ID
- MCC-88-GYN-13
- Status last verified
- Nov 2025
- First submitted
- 13 Jul 2020
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lasher A, Harris LE, Solomon AL, Harbin LM, Raby L, Dietrich CS, Kryscio RJ, van Nagell JR, Pavlik EJ. Variables Associated With Resolution and Persistence of Ovarian Cysts. Obstet Gynecol. 2023 Dec 1;142(6):1293-1301. doi: 10.1097/AOG.0000000000005411. Epub 2023 Oct 12.
PubMed 38051292
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04473833
- Acronym / sponsor ID
- MCC-88-GYN-13
- Conditions
- Ovarian Cancer
- Keywords
- serial, transvaginal ultrasonography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65,000 participants (estimated)
- Lead sponsor
- John R van NagellUniversity, hospital or other
- Study start
- 19 Dec 1988 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Women from every Kentucky county participate in the Kentucky Ovarian Cancer Screening Program. Screening sites include: Maysville, Prestonsburg, Greenup, Elizabethtown, Somerset, Paducah and Lexington. Offsite participants account for 14% of the screening population with 86% being screened in Lexington. The long-term survival (20 year) of women with screen-detected ovarian cancers is twice that of unscreened women (65% vs 32%). Separation of cases into Type 1 and Type 2 ovarian cancer shows that screening improves the survival of both Type 1 and Type 2 ovarian cancers. Type 1 ovarian carcinomas for the screened and unscreened populations were defined based on these WHO criteria: mucinous carcinomas all grade, clear cell carcinomas all grades, endometrioid carcinomas grades 1 \& 2, serous carcinomas grades 1 \& 2, and malignant Brenner's tumors all grades. Type 2 ovarian carcinomas for the screened and unscreened populations were defined based on these criteria: undifferentiated carcinomas, endometrioid carcinomas grade 3, serous carcinomas grade 3, and carcinosarcomas.
While long-term 20-year survival of women with Type 1 ovarian cancers detected by screening was significantly better than for unscreened women (81% v 46%, respectively), the survival benefit was even more pronounced for Type 2 ovarian cancers detected by screening of Kentucky women compared to unscreened Kentucky women (55.7% vs. 0.3%, respectively) or unscreened women at UK Hospital (12%). Screen-detected cases of Type 2 invasive ovarian cancers had better survival than unscreened cases when those detected had early- or late-stage disease. However, better survival was achieved when Type 2 ovarian cancers were detected at an early (72%) compared to late-stage (46%). Our data support the effectiveness of the screening protocol at the University of Kentucky, and subsequent treatment in accordance with National Comprehensive Cancer Network guidelines.
The significance of these findings is that our approach has resulted in the detection of both early-stage Type 1 and Type 2 ovarian cancers and these cases have had improved survival when compared to that of unscreened cases, indicating that the screen-detected cases are associated with a potential survival advantage even for aggressive ovarian carcinomas.
The primary objective of this study is to prospectively evaluate the false positive (FP) percentage generated by the ovarian screening algorithm and determine whether serial transvaginal ultrasonography can lower the FP percentage as demonstrated in the retrospective analysis. The aim of serial ultrasonography is to decrease FP percentage to 0.32% (positive predictive value of 24%) without adversely impacting the results for true positives and false negatives. on a "per woman screened basis" since this corresponds to a minimally acceptable positive predictive value of 24% or higher. This assumes an average of three screening years for each new woman entering the program.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants in the Kentucky Ovarian Cancer Screening Program | Experimental | Procedure: Serial Transvaginal UltrasonographyParticipants from the Kentucky Ovarian Cancer Screening Program who choose to participate in this trial will undergo further serial transvaginal ultrasonography (TVS) screening. |
Who may qualify
- Ages
- 24 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial Transvaginal UltrasonographyParticipants 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. | Procedure or surgery | Participants in the Kentucky Ovarian Cancer Screening Program |
Primary outcome
False-positive (FP) percentage
Time frame: approximately 3 years
Measure the false-positive (FP) rate generated by the ovarian screening algorithm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Derived from this study: PubMed 38051292Lasher A, Harris LE, Solomon AL, Harbin LM, Raby L, Dietrich CS, Kryscio RJ, van Nagell JR, Pavlik EJ. Variables Associated With Resolution and Persistence of Ovarian Cysts. Obstet Gynecol. 2023 Dec 1;142(6):1293-1301. doi: 10.1097/AOG.0000000000005411. Epub 2023 Oct 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John R Van Nagell, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial Transvaginal Ultrasonography in people with Ovarian Cancer, run by John R van Nagell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward J Pavlik, PhD (859-323-3830, edward.pavlik@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False-positive (FP) percentage (time frame: approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.