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
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|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|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|
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
Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
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
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
- change in symptom relief (patient interview) [ Time Frame: 12, 24, 36 months ]degree to which bleeding and pain from uterine fibroids is alleviated
- 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
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
|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|
|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|
|Principal Investigator:||Evan R Myers, MD||Duke University|