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Completed

NCT Number: NCT02227654

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

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.

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abnormal Ovarian Ultrasound

Procedure

Ultrasound

Primary outcomes

  1. 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.

Secondary outcomes

  1. Surgical complications

    Time frame: Up to 12 months

    Surgical complications including type, severity, and resolution.

  2. Compliance to the treatment algorithm

    Time frame: Up to 12 months

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

Sponsors and collaborators

Lead sponsor

Frederick R. Ueland, M.D.

Other

Collaborators

  • Lucille P. Markey Cancer Center at University of Kentucky

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2014
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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