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Patient Centered Results for Uterine Fibroids (COMPARE-UF)

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ClinicalTrials.gov Identifier: NCT02260752
Recruitment Status : Active, not recruiting
First Posted : October 9, 2014
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date September 29, 2014
First Posted Date October 9, 2014
Last Update Posted Date April 9, 2019
Study Start Date November 2015
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2014)
change in symptom relief (patient interview) [ Time Frame: 12, 24, 36 months ]
degree to which bleeding and pain from uterine fibroids is alleviated
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02260752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 6, 2014)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Centered Results for Uterine Fibroids
Official Title Comparing Options for Management: Patient Centered Results for Uterine Fibroids
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.

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples Without DNA
Description:
blood assay
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.
Condition Fibroids, Uterine
Intervention
  • 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
  • Drug: Medical Therapy
    treatment of uterine fibroids with only medications, no procedure or surgery is used
  • 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
Study Groups/Cohorts
  • Medical
    Patients who receive medical therapy only for treatment of their uterine fibroids
    Intervention: Drug: Medical Therapy
  • Procedure
    Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
    Interventions:
    • Procedure: hysterectomy
    • Procedure: Uterine arterial embolization
    • Procedure: myomectomy
    • Procedure: endometrial ablation
    • Procedure: magnetic resonance guided focused ultrasound
    • Procedure: radiofrequency ablation
Publications * Stewart EA, Lytle BL, Thomas L, Wegienka GR, Jacoby V, Diamond MP, Nicholson WK, Anchan RM, Venable S, Wallace K, Marsh EE, Maxwell GL, Borah BJ, Catherino WH, Myers ER. The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design. Am J Obstet Gynecol. 2018 Jul;219(1):95.e1-95.e10. doi: 10.1016/j.ajog.2018.05.004. Epub 2018 May 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 5, 2019)
3094
Original Estimated Enrollment
 (submitted: October 6, 2014)
10000
Estimated Study Completion Date April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 54 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02260752
Other Study ID Numbers Pro00057883
RFA-HS-14-006 ( Other Grant/Funding Number: Agency for Healthcare Research and Quality )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Evan R Myers, MD Duke University
PRS Account Duke University
Verification Date April 2019