NCT02227654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
2 years until next milestone

Study Start

First participant enrolled

September 12, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2022

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

6 years

First QC Date

August 26, 2014

Last Update Submit

February 28, 2023

Conditions

Ovarian Neoplasms

Keywords

OvaryCancerMorphologySurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Surgical complications

    Up to 12 months

  • Compliance to the treatment algorithm

    Up to 12 months

Study Arms (1)

Abnormal Ovarian Ultrasound

EXPERIMENTAL

Abnormal Ovarian Ultrasound

Procedure: Abnormal Ovarian Ultrasound

Interventions

Abnormal Ovarian UltrasoundPROCEDURE

Ultrasound

Abnormal Ovarian Ultrasound

Eligibility Criteria

Age25 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBecause 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.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Frederick R. Ueland, M.D.

    Markey Cancer Center, University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 28, 2014

Study Start

September 12, 2016

Primary Completion

September 7, 2022

Study Completion

September 7, 2022

Last Updated

March 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)