Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
John R van Nagell
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 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.
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 carcinoma…
Eligibility
- Age range
- 24+ years
- Sex
- Female
- Healthy volunteers
- Yes
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…
Interventions
- ProcedureSerial Transvaginal Ultrasonography
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.
Location
- Markey Cancer CenterLexington, Kentucky