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

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ClinicalTrials.gov Identifier: NCT02227654
Recruitment Status : Recruiting
First Posted : August 28, 2014
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Lucille P. Markey Cancer Center at University of Kentucky
Information provided by (Responsible Party):
Frederick R. Ueland, M.D., University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Procedure: Abnormal Ovarian Ultrasound Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3290 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
Study Start Date : September 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Abnormal Ovarian Ultrasound
Abnormal Ovarian Ultrasound
Procedure: Abnormal Ovarian Ultrasound
Ultrasound




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227654


Contacts
Contact: Frederick R. Ueland, M.D. 859 257-1613 fuela0@uky.edu

Locations
United States, Kentucky
Markey Cancer Center, University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Principal Investigator: Frederick R. Ueland, M.D.         
Sponsors and Collaborators
Frederick R. Ueland, M.D.
Lucille P. Markey Cancer Center at University of Kentucky
Investigators
Principal Investigator: Frederick R. Ueland, M.D. Markey Cancer Center, University of Kentucky

Responsible Party: Frederick R. Ueland, M.D., Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02227654     History of Changes
Other Study ID Numbers: 14-GYN-200
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

Keywords provided by Frederick R. Ueland, M.D., University of Kentucky:
Ovary
Cancer
Morphology
Surgery

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders