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Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT02227654•Frederick R. Ueland, M.D.

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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.

Eligibility

Age

25 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, United States

Key Dates

Start Date

September 12, 2016

Primary Completion Date

September 7, 2022

Completion Date

September 7, 2022

Last Updated

March 2, 2023

Enrollment

179

ACTUAL participants

Conditions

Ovarian Neoplasms

Interventions

Abnormal Ovarian Ultrasound

PROCEDURE

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

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RECRUITINGPHASE1/PHASE2

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

NCT06051695

Solid Tumor, AdultColorectal Cancer+18 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques

Establishment of a Tumor Bank for Tissue Samples

Institut Paoli Calmettes Ovarian Cancer Database