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

Ovarian Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227654
• Other study ID #: 14-GYN-200
• Status: Completed
• Phase: N/A
• Start date: September 12, 2016
• Est. completion date: September 7, 2022

Study information

• Verified date: February 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Procedure:
• Abnormal Ovarian Ultrasound
Ultrasound

Locations

Country	Name	City	State
United States	Markey Cancer Center, University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Frederick R. Ueland, M.D.	Lucille P. Markey Cancer Center at University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical complications	Surgical complications including type, severity, and resolution.	Up to 12 months
Secondary	Compliance to the treatment algorithm	Percentage of required visits that were attended for each individual's treatment algorithm	Up to 12 months