Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
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|ClinicalTrials.gov Identifier: NCT02227654|
Recruitment Status : Recruiting
First Posted : August 28, 2014
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms||Procedure: Abnormal Ovarian Ultrasound||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3290 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2022|
Experimental: Abnormal Ovarian Ultrasound
Abnormal Ovarian Ultrasound
Procedure: Abnormal Ovarian Ultrasound
- Positive predictive value (PPV) of ovarian cancer screening [ Time Frame: Up to 12 months ]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.
- Surgical complications [ Time Frame: Up to 12 months ]Surgical complications including type, severity, and resolution.
- Compliance to the treatment algorithm [ Time Frame: Up to 12 months ]Percentage of required visits that were attended for each individual's treatment algorithm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227654
|Contact: Frederick R. Ueland, M.D.||859 firstname.lastname@example.org|
|United States, Kentucky|
|Markey Cancer Center, University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator: Frederick R. Ueland, M.D.|
|Principal Investigator:||Frederick R. Ueland, M.D.||Markey Cancer Center, University of Kentucky|