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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 compared to a historical control from 15% to 25%. Secondary Objective To measure the compliance for study participants enrolled on the treatment algorithm using serial transvaginal ultrasound with a tumor morphology index. Exploratory Objective To determine the effectiveness of a treatment algorithm that combines serum biomarkers aloneor in combination with transvaginal ultrasound to reduce the false positive rate of ovarian cancer screening in the subset of women agreeing to biomarker collection.

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

Conditions
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Ovarian Neoplasms

Intervention / Treatment
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* Procedure: Abnormal Ovarian Ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abnormal Ovarian Ultrasound<br>Abnormal Ovarian Ultrasound | Procedure: Abnormal Ovarian Ultrasound<br>* Ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Surgical complications including type, severity, and resolution. | Up to 12 months | 
| Compliance to the treatment algorithm | Percentage of required visits that were attended for each individual's treatment algorithm | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovary, Cancer, Morphology, Surgery