Transvaginal Ultrasound Screening for Ovarian Cancer
What You Need to Know Before You Apply
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.
Is transvaginal ultrasound screening for ovarian cancer safe for humans?
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.12356
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.12345
Who Is on the Research Team?
John R Van Nagell, MD
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Serial Transvaginal Ultrasonography
Participants undergo serial transvaginal ultrasonography (TVS) screening to detect ovarian cancer
Follow-up
Participants are monitored for safety and effectiveness after screening
What Are the Treatments Tested in This Trial?
Interventions
- Serial Transvaginal Ultrasonography
Serial Transvaginal Ultrasonography is already approved in United States, European Union for the following indications:
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Who Is Running the Clinical Trial?
John R van Nagell
Lead Sponsor