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

Primary Purpose

Ovarian Neoplasms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Abnormal Ovarian Ultrasound

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Ovary, Cancer, Morphology, Surgery

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Markey Cancer Center, University of Kentucky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abnormal Ovarian Ultrasound

Arm Description

Abnormal Ovarian Ultrasound

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical complications

Surgical complications including type, severity, and resolution.

Compliance to the treatment algorithm

Percentage of required visits that were attended for each individual's treatment algorithm

Full Information

NCT ID

NCT02227654

First Posted

August 26, 2014

Last Updated

February 28, 2023

Sponsor

Frederick R. Ueland, M.D.

Collaborators

Lucille P. Markey Cancer Center at University of Kentucky

1. Study Identification

Unique Protocol Identification Number

NCT02227654

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 Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

September 12, 2016 (Actual)

Primary Completion Date

September 7, 2022 (Actual)

Study Completion Date

September 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Frederick R. Ueland, M.D.

Collaborators

Lucille P. Markey Cancer Center at University of Kentucky

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Neoplasms

Keywords

Ovary, Cancer, Morphology, Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

179 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abnormal Ovarian Ultrasound

Arm Type

Experimental

Arm Description

Abnormal Ovarian Ultrasound

Intervention Type

Procedure

Intervention Name(s)

Abnormal Ovarian Ultrasound

Intervention Description

Ultrasound

Primary Outcome Measure Information:

Title

Positive predictive value (PPV) of ovarian cancer screening

Description

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Surgical complications

Description

Surgical complications including type, severity, and resolution.

Time Frame

Up to 12 months

Title

Compliance to the treatment algorithm

Description

Percentage of required visits that were attended for each individual's treatment algorithm

Time Frame

Up to 12 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Because ovarian cancer is a disease of only women, men are not included in this study, but women of all races and ethnic groups are eligible for this trial.

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederick R. Ueland, M.D.

Organizational Affiliation

Markey Cancer Center, University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

Markey Cancer Center, University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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