RECRUITINGINTERVENTIONAL

Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer

About 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - You should be able to carry out daily activities with 0 level of ability (ECOG 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 willing to sign a consent form document. Who Should NOT Join This Trial: - 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 willing to sign a consent form component or personal information needed for the study Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

Serial 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.

Locations (1)

Markey Cancer Center

Lexington, Kentucky, United States