Screening for ovarian cancer using transvaginal ultrasound

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.