Status:
COMPLETED
Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
Lead Sponsor:
Frederick R. Ueland, M.D.
Collaborating Sponsors:
Lucille P. Markey Cancer Center at University of Kentucky
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
25+ years
Phase:
NA
Brief 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...
Detailed Description
Primary Objective: To determine if a treatment algorithm using serial transvaginal ultrasound with a tumor morphology index can improve the positive predictive value (PPV) of ovarian cancer screening...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT02227654
Start Date
September 12 2016
End Date
September 7 2022
Last Update
March 2 2023
Active Locations (1)
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1
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536