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Summary

for females ages 18–54 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF. Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.

Official Title

Comparing Options for Management: Patient Centered Results for Uterine Fibroids

Details

COMPARE UF will enroll approximately 10,000 subjects across 9 clinical enrolling centers in the US. We anticipate recruitment to last approximately 24 months. Sites will consent interested patients and have them complete a patient contact information form to be used to contact the patient for telephone interviews. Following informed consent, the site will collect clinical information and several patient-reported outcomes scales, including the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL), the Menopausal Rating Scale, and the EQ-5D, a standardized measure of general health outcomes.

In year 01 of this study, among patients receiving a procedure to treat their UF, 1000 will be asked to provide two blood samples: the first at time of enrollment (before the procedure) and the second at 12 months after the procedure. Samples will be evaluated for ovarian reserve via a blood assay measurement of anti-mullerian hormone.

Additionally, for patients who have a procedure to treat their UF, they will have a routine clinic follow-up visit, sometime between 6 - 12 weeks post procedure. Additional clinical data will be collected at this time.

For patients who are treated medically, there will be no further study-related clinic visits. Follow-up will occur exclusively by telephone.

All consented patients will complete telephone interviews at approximately 12, 24, and 36 months following the initial procedure. It is anticipated that patients enrolled during the first study year will complete a maximum of three years of follow-up. However, if additional funds become available, the investigators plan to extend the follow-up of enrolled patients to five years.

Keywords

Fibroids, Uterine

Eligibility

You can join if…

Open to females ages 18–54

  • Diagnosis of UF by imaging or pathology report within 2 years of enrollment initiation.
  • Menstrual period within 12 months

You CAN'T join if...

  • Post-menopausal
  • Men
  • 55 years old or older

Locations

  • Mayo Clinic
    Rochester, Minnesota, 55905, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi, 39216, United States
  • Northwestern University
    Chicago, Illinois, 60611, United States
  • Henry Ford Health System
    Detroit, Michigan, 48202, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina, 27599, United States
  • Inova Health Systems
    Falls Church, Virginia, 22042, United States
  • Uniformed Services University of the Health Sciences
    Bethesda, Maryland, 20814, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts, 02115, United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Duke University
Links
COMPARE-UF Registry website
ID
NCT02260752
Study Type
Observational [Patient Registry]
Last Updated
February 1, 2017