Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
Completed · Not applicable
Conditions studied: Ovarian Neoplasms
In brief
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.
Key facts
- Study ID
- NCT02227654
- Run by
- Frederick R. Ueland, M.D.
- People needed
- 179
- Starts
- 2016-09-12
- Expected to finish
- 2022-09-07
- Last updated by the study team
- 2023-03-02
Who can join
Age: 25 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Markey Cancer Center, University of Kentucky — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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