Spots Global Cancer Trial Database for Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors

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Trial Identification

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

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

Study ID: NCT02227654

Conditions

Ovarian Neoplasms

Interventions

Abnormal Ovarian Ultrasound

Study Description

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 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: 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.