Patient Centered Results for Uterine Fibroids
Condition: Fibroids, Uterine
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational [Patient Registry]

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.
    

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.
    

Intervention name(s): hysterectomy; Uterine arterial embolization; myomectomy; Medical Therapy; endometrial ablation; magnetic resonance guided focused ultrasound; radiofrequency ablation
Intervention type(s): Procedure; Procedure; Procedure; Drug; Procedure; Procedure; Procedure
Intervention description(s): surgical removal of the uterus; 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.; surgical procedure to remove uterine fibroids, but does not remove uterus; treatment of uterine fibroids with only medications, no procedure or surgery is used; surgical procedure that destroys uterine lining via a telescope placed inside the uterus; procedure that destroys fibroids while inside an MRI machine; procedure that uses heat to destroy uterine fibroids
Other intervention name(s): UAE; NovaSure, Her Option, HydroTherm; MRgFUS, ExAblate; Sonalleve; Accessa
Observational model: Cohort
Time perspective: Prospective
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.
      
Biospecimen description: 
      blood assay