Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
Conditions
Ovarian Neoplasms
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
Ovary, Cancer, Morphology, Surgery
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Abnormal Ovarian Ultrasound
Type: Procedure
Overall Status
Not yet recruiting
Summary
The present investigation will prospectively evaluate whether serial transvaginal ultrasonography with Morphology Index (MI) can further reduce false positive results by more accurately distinguishing benign from malignant ovarian tumors. If there is no change in the detection of true positive cases, the result will be an increase in the positive predictive value of ovarian cancer screening.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 25 Years
Gender: Female
Criteria: Inclusion Criteria:

- Women must be enrolled in the University of Kentucky Ovarian Cancer Screening Program

- 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.

- Patients must have a Gynecologic Oncology Group performance status of 0-3.

- Life expectancy of greater than 6 months is required for study participation.

- 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.
Location
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Status: Not yet recruiting
Start Date
June 2015
Completion Date
August 2022
Sponsors
Frederick R. Ueland, M.D.
Source
University of Kentucky
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page