Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors

NCT02227654CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Frederick R. Ueland, M.D.

Enrollment

179

Start Date

2016-09-12

Completion Date

2022-09-07

Study Type

INTERVENTIONAL

Official Title

Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors

Interventions

Abnormal Ovarian Ultrasound

Conditions

Ovarian Neoplasms

Eligibility

Age Range

25 Years+

Sex

FEMALE

Inclusion Criteria:

* Women must be enrolled in the University of Kentucky Ovarian Cancer Screening Program Eligibility criteria for the OCSP are: 50 years of age or older, or be postmenopausal and have not had a prior salpingo-oophorectomy or have a family history of ovarian cancer in a primary relative or have a self-history of breast cancer.
* Patients have a documented ovarian abnormality on ultrasound
* Patients having undergone prior hysterectomy will be eligible provided that they meet the other requirements for entry into this study.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who are not enrolled in the University of Kentucky Ovarian Cancer Screening Program .
* Patients who cannot tolerate the vaginal ultrasound procedure.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients who are referred with pelvic symptoms, a known pelvic mass, or a history of prior radiation, will be excluded from this investigation.
* History of ovarian cancer.
* Prior bilateral salpingo-oophorectomy.
* Prisoners.
* Women who are currently pregnant.

Outcome Measures

Primary Outcomes

Positive predictive value (PPV) of ovarian cancer screening

Whether the treatment algorithm for patients with abnormal ultrasounds improves the positive predictive value of ultrasounds as ovarian screening tests, thus lowering the false positive rate compared to historical controls.

Time frame: Up to 12 months

Secondary Outcomes

Surgical complications

Surgical complications including type, severity, and resolution.

Time frame: Up to 12 months

Compliance to the treatment algorithm

Percentage of required visits that were attended for each individual's treatment algorithm

Time frame: Up to 12 months

Locations

Markey Cancer Center, University of Kentucky, Lexington, United States