Transvaginal Ultrasound Screening for Ovarian Cancer

Overseen By Edward J Pavlik, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: John R van Nagell

Disqualifiers: Pelvic symptoms, Pelvic mass, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

65000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Serial Transvaginal Ultrasonography for ovarian cancer screening?

Research shows that using transvaginal sonography (TVS) for screening in postmenopausal women can detect ovarian abnormalities early, including ovarian tumors and early-stage cancers, which are often missed by other methods. In studies, women screened with TVS had no deaths from ovarian cancer, suggesting it may help catch the disease early when it's more treatable. ^{1 2 3 4 5}

Is transvaginal ultrasound screening for ovarian cancer safe for humans?

Transvaginal ultrasound screening for ovarian cancer has been used in large studies involving thousands of women, and it is described as time-efficient, easy to perform, and well-accepted by patients, with no reported deaths due to the procedure itself. ^{1 2 3 4 5}

How does transvaginal ultrasound screening differ from other treatments for ovarian cancer?

Transvaginal ultrasound screening is unique because it is a non-invasive imaging technique used to detect ovarian abnormalities early, especially in asymptomatic women, rather than treating existing cancer. Unlike other treatments that address cancer after diagnosis, this method focuses on early detection to improve outcomes. ^{1 2 3 4 6}

Research Team

John R Van Nagell, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for women over 50, or those with a family history of ovarian cancer over 24 years old, and women over 24 with a personal history of breast cancer. Participants must have at least one ovary, be able to consent, and have an ECOG performance status up to 2.34. It excludes symptomatic individuals, prisoners, pregnant women, those unable to understand the study or give informed consent.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

I am a woman aged over 50 years.

I have had a hysterectomy but still have at least one ovary.

Exclusion Criteria

I have had ovarian cancer in the past.

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

You cannot have a transvaginal ultrasound because of issues with vaginal size, infections, or difficulty placing your body in the right position for the test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Serial Transvaginal Ultrasonography

Participants undergo serial transvaginal ultrasonography (TVS) screening to detect ovarian cancer

3 years

Regular visits as per screening protocol

Follow-up

Participants are monitored for safety and effectiveness after screening

4 weeks

Treatment Details

Interventions

• Serial Transvaginal Ultrasonography

Trial Overview The study tests if serial transvaginal ultrasonography can effectively screen for ovarian cancer in high-risk women by reducing false positives and increasing positive predictive value without missing true cases or creating false negatives. Women will receive ongoing screening based on a specific algorithm.

Participant Groups

Group I: Participants in the Kentucky Ovarian Cancer Screening Program Experimental Treatment 1 Intervention

Participants from the Kentucky Ovarian Cancer Screening Program who choose to participate in this trial will undergo further serial transvaginal ultrasonography (TVS) screening.

Serial Transvaginal Ultrasonography is already approved in United States, European Union for the following indications:

Approved in United States as Transvaginal Ultrasonography for:

• Screening for ovarian cancer in intermediate to high-risk women

Approved in European Union as Transvaginal Ultrasonography for:

• Diagnostic imaging for ovarian abnormalities

Who Is Running the Clinical Trial?

John R van Nagell

Lead Sponsor

Trials

1

Recruited

65,000+

Findings from Research

Annual transvaginal sonography (TVS) screening in 14,469 asymptomatic women significantly improved the early detection of ovarian cancer, with 17 cancers identified, mostly at earlier stages (Stage I and II), leading to high survival rates of 95% at 2 years for screened patients.

While TVS screening showed high sensitivity (81%) and specificity (98.9%), it was less effective in detecting cancers when ovarian volume was normal, indicating that normal scans do not guarantee the absence of disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of transvaginal sonographic screening in asymptomatic women at risk for ovarian cancer. van Nagell, JR., DePriest, PD., Reedy, MB., et al.[2016]

Annual transvaginal sonography (TVS) screening in over 25,000 women showed a high sensitivity (85.0%) and specificity (98.7%) for detecting ovarian cancer, leading to earlier stage detection and improved survival rates for patients diagnosed through screening.

Despite its effectiveness, TVS screening had limitations, including false-negative results where some women developed ovarian cancer within 12 months of a negative screen, highlighting the need for continued monitoring even after normal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer screening with annual transvaginal sonography: findings of 25,000 women screened. van Nagell, JR., DePriest, PD., Ueland, FR., et al.[2022]

In a study involving 43,867 postmenopausal women from the UKCTOCS trial, factors such as previous hysterectomy, age, and obesity significantly decreased the likelihood of visualizing ovaries during transvaginal sonography (TVS).

Conversely, a history of infertility and older age at menopause were associated with better ovarian visualization, highlighting the importance of these factors in ovarian cancer screening strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors affecting visualization of postmenopausal ovaries: descriptive study from the multicenter United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Sharma, A., Burnell, M., Gentry-Maharaj, A., et al.[2022]

Transvaginal sonography (TVS) was effective in screening 1300 asymptomatic postmenopausal women for ovarian abnormalities, detecting issues in 2.5% of participants, including two cases of Stage I ovarian carcinoma.

Both women diagnosed with ovarian cancer had normal pelvic exams and CA-125 levels, highlighting the importance of TVS as a reliable screening tool, as there have been no deaths from ovarian cancer in over 3000 patient years of follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography. Van Nagell, JR., DePriest, PD., Puls, LE., et al.[2019]

In a study involving 3220 asymptomatic postmenopausal women screened with transvaginal sonography (TVS), the method successfully identified ovarian abnormalities, leading to the detection of three cases of early-stage ovarian cancer, all of whom are alive after treatment.

The screening demonstrated a reduction in the stage at which ovarian cancer was detected and has not resulted in any ovarian cancer deaths among the screened population, suggesting that TVS could be an effective screening tool for early detection of ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer screening in asymptomatic postmenopausal women. DePriest, PD., van Nagell, JR., Gallion, HH., et al.[2016]

The combination of serum CA125 levels exceeding 30 U/ml and a Transvaginal Ultrasound (TVUS) score of 35 or higher demonstrated a high sensitivity of 81.7% and perfect specificity of 100% for predicting ovarian cancer in a study of 120 women.

This study suggests that using both CA125 and TVUS together can provide a reliable method for screening ovarian cancer, but further research with a larger population is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum CA 125 combined with transvaginal ultrasonography for ovarian cancer screening. Roupa, Z., Faros, E., Raftopoulos, V., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The efficacy of transvaginal sonographic screening in asymptomatic women at risk for ovarian cancer. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Ovarian cancer screening with annual transvaginal sonography: findings of 25,000 women screened. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Factors affecting visualization of postmenopausal ovaries: descriptive study from the multicenter United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Ovarian cancer screening in asymptomatic postmenopausal women. [2016]

6. Greece pubmed.ncbi.nlm.nih.gov

Serum CA 125 combined with transvaginal ultrasonography for ovarian cancer screening. [2019]