RECRUITING

Transvaginal Ultrasonography As a Screening Method for Ovarian Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a large, prospective, single-arm cohort study of transvaginal ultrasonographic screening for ovarian cancer in intermediate to high-risk women from Kentucky. Detection of ovarian malignancy often occurs subsequent to the initial transvaginal sonography (TVS) screen; therefore, it is important to offer continued screening to study participants based on our published algorithm. Screening will be available to participants for as long as they elect to receive it. The primary study endpoints are to determine if prospective serial transvaginal ultrasonography can decrease the false-positive (FP) percentage and improve the positive predictive value (PPV) as suggested by retrospective analysis without compromising the detection of true positives or promote the occurrence of false negatives.

Official Title

Transvaginal Ultrasonography As a Screening Method for Ovarian Cancer

Quick Facts

Study Start:1988-12-19
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04473833

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * women over the age of 50 years;
  2. * women with a documented family history of ovarian cancer over the age of 24 years;
  3. * women over the age of 24 years with a personal history of breast cancer
  4. * ECOG performance status of 0 to 2.34
  5. * Subjects having undergone prior hysterectomy will be eligible provided that they meet the other requirements for entry into this study and have at least one ovary.
  6. * Ability to understand and the willingness to sign a written informed consent document.
  1. * Women who are referred with pelvic symptoms, a known pelvic mass or a history of prior radiation.
  2. * Individuals that cannot safely receive transvaginal ultrasound due to vaginal size, vaginal infections, lack of bowel or bladder control or inability to physically place their body in position to receive transvaginal ultrasound
  3. * Prisoners
  4. * Pregnant women
  5. * Women with a prior history of ovarian cancer
  6. * Exclusions will apply to anyone who presents with factors or issues that prevent them from understanding the screening research procedures or completing the informed consent component or personal information needed for the study

Contacts and Locations

Study Contact

Edward J Pavlik, PhD
CONTACT
859-323-3830
edward.pavlik@uky.edu

Principal Investigator

John R Van Nagell, MD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

Markey Cancer Center
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: John R van Nagell

  • John R Van Nagell, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date1988-12-19
Study Completion Date2026-12-31

Study Record Updates

Study Start Date1988-12-19
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • serial
  • transvaginal ultrasonography

Additional Relevant MeSH Terms

  • Ovarian Cancer