Screening for ovarian cancer using transvaginal ultrasound
Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
This study is testing if regular transvaginal ultrasounds can help women at higher risk for ovarian cancer catch it earlier and improve their chances of survival.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65000 (estimated) |
| Ages | 24 Years and up |
| Sex | Female |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT04473833 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of serial transvaginal ultrasonography as a screening method for ovarian cancer in women at intermediate to high risk. Participants from various counties in Kentucky will undergo regular screenings based on a published algorithm to monitor for ovarian malignancies. The study aims to reduce false-positive rates and improve the positive predictive value of the screening without missing true positive cases. The long-term survival rates of women with screen-detected ovarian cancers will also be assessed.
Who should consider this trial
Good fit: Ideal candidates include women over 50, those with a family history of ovarian cancer, or those with a personal history of breast cancer.
Not a fit: Patients with known pelvic masses, prior ovarian cancer, or those who cannot safely undergo transvaginal ultrasound will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve early detection rates of ovarian cancer, leading to better survival outcomes for patients.
How similar studies have performed: Previous studies have indicated that screening can improve survival rates for ovarian cancer, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lexington, Kentucky
- Markey Cancer Center — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: John R Van Nagell, MD — University of Kentucky
- Study coordinator: Edward J Pavlik, PhD
- Email: edward.pavlik@uky.edu
- Phone: 859-323-3830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.