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Patient Centered Results for Uterine Fibroids (COMPARE-UF)

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ClinicalTrials.gov Identifier: NCT02260752
Recruitment Status : Enrolling by invitation
First Posted : October 9, 2014
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease Intervention/treatment
Fibroids, Uterine Procedure: hysterectomy Procedure: Uterine arterial embolization Procedure: myomectomy Drug: Medical Therapy Procedure: endometrial ablation Procedure: magnetic resonance guided focused ultrasound Procedure: radiofrequency ablation

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Comparing Options for Management: Patient Centered Results for Uterine Fibroids
Study Start Date : November 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Group/Cohort Intervention/treatment
Medical
Patients who receive medical therapy only for treatment of their uterine fibroids
Drug: Medical Therapy
treatment of uterine fibroids with only medications, no procedure or surgery is used

Procedure
Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
Procedure: hysterectomy
surgical removal of the uterus

Procedure: Uterine arterial embolization
In uterine artery embolization, doctor uses a slender, flexible tube (catheter) to inject small particles (embolic agents) into the uterine arteries, which supply blood to your fibroids and uterus.the embolic agents are injected into these fibroid blood vessels. The goal is to block the fibroid vessels, starving the fibroids and causing them to shrink and die.
Other Name: UAE

Procedure: myomectomy
surgical procedure to remove uterine fibroids, but does not remove uterus

Procedure: endometrial ablation
surgical procedure that destroys uterine lining via a telescope placed inside the uterus
Other Name: NovaSure, Her Option, HydroTherm

Procedure: magnetic resonance guided focused ultrasound
procedure that destroys fibroids while inside an MRI machine
Other Name: MRgFUS, ExAblate; Sonalleve

Procedure: radiofrequency ablation
procedure that uses heat to destroy uterine fibroids
Other Name: Accessa




Primary Outcome Measures :
  1. change in symptom relief (patient interview) [ Time Frame: 12, 24, 36 months ]
    degree to which bleeding and pain from uterine fibroids is alleviated


Secondary Outcome Measures :
  1. change in preservation reproductive function (patient interview) [ Time Frame: 12, 24, 36 months ]
    ability of a woman after receiving treatment for uterine fibroids can conceive and deliver a healthy baby


Biospecimen Retention:   Samples Without DNA
blood assay


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
10,000 patients diagnosed with UF between the ages of 18 and 54. Patients must have had a menstrual period within the last 12 months. Source documentation of UF must include either imaging or a pathology report.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT02260752


Locations
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United States, California
University of California Medical Centers
San Francisco, California, United States, 94143
United States, Maryland
Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Virginia
Inova Health Systems
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Evan R Myers, MD Duke University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02260752     History of Changes
Other Study ID Numbers: Pro00057883
RFA-HS-14-006 ( Other Grant/Funding Number: Agency for Healthcare Research and Quality )
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases