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

NCT ID: NCT02227654

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-12
• Study Completion Date: 2022-09-07

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.

Conditions

Ovarian Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abnormal Ovarian Ultrasound

Abnormal Ovarian Ultrasound

Group Type: EXPERIMENTAL

Abnormal Ovarian Ultrasound

Intervention Type: PROCEDURE

Ultrasound

Interventions

Abnormal Ovarian Ultrasound

Ultrasound

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lucille P. Markey Cancer Center at University of Kentucky

OTHER

Sponsor Role: collaborator

Frederick R. Ueland, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Frederick R. Ueland, M.D.

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Frederick R. Ueland, M.D.

Role: PRINCIPAL_INVESTIGATOR

Markey Cancer Center, University of Kentucky

Locations

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

14-GYN-200

Identifier Type: -

Identifier Source: org_study_id