<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02260752</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00057883</org_study_id>
    <secondary_id>RFA-HS-14-006</secondary_id>
    <nct_id>NCT02260752</nct_id>
  </id_info>
  <brief_title>Patient Centered Results for Uterine Fibroids</brief_title>
  <acronym>COMPARE-UF</acronym>
  <official_title>Comparing Options for Management: Patient Centered Results for Uterine Fibroids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this project is to better enable patients with uterine fibroids (UF) to&#xD;
      make informed decisions about treatment options by leveraging the highest possible evidence&#xD;
      of healthcare quality. The foundation of this project will be a multi-site, prospective&#xD;
      registry of a diverse group of women who have undergone either medical or surgical treatment&#xD;
      for UF.&#xD;
&#xD;
      Specifically, the investigators are interested in: comparing management options for symptom&#xD;
      relief; comparing management options for preserving reproductive function; and comparing&#xD;
      effectiveness among different subpopulations, including consideration of patient needs and&#xD;
      preferences of treatment options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COMPARE UF will enroll approximately 10,000 subjects across 9 clinical enrolling centers in&#xD;
      the US. We anticipate recruitment to last approximately 24 months. Sites will consent&#xD;
      interested patients and have them complete a patient contact information form to be used to&#xD;
      contact the patient for telephone interviews. Following informed consent, the site will&#xD;
      collect clinical information and several patient-reported outcomes scales, including the&#xD;
      Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL), the Menopausal Rating Scale,&#xD;
      and the EQ-5D, a standardized measure of general health outcomes.&#xD;
&#xD;
      In year 01 of this study, among patients receiving a procedure to treat their UF, 1000 will&#xD;
      be asked to provide two blood samples: the first at time of enrollment (before the procedure)&#xD;
      and the second at 12 months after the procedure. Samples will be evaluated for ovarian&#xD;
      reserve via a blood assay measurement of anti-mullerian hormone.&#xD;
&#xD;
      Additionally, for patients who have a procedure to treat their UF, they will have a routine&#xD;
      clinic follow-up visit, sometime between 6 - 12 weeks post procedure. Additional clinical&#xD;
      data will be collected at this time.&#xD;
&#xD;
      For patients who are treated medically, there will be no further study-related clinic visits.&#xD;
      Follow-up will occur exclusively by telephone.&#xD;
&#xD;
      All consented patients will complete telephone interviews at approximately 12, 24, and 36&#xD;
      months following the initial procedure. It is anticipated that patients enrolled during the&#xD;
      first study year will complete a maximum of three years of follow-up. However, if additional&#xD;
      funds become available, the investigators plan to extend the follow-up of enrolled patients&#xD;
      to five years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>change in symptom relief (patient interview)</measure>
    <time_frame>12, 24, 36 months</time_frame>
    <description>degree to which bleeding and pain from uterine fibroids is alleviated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in preservation reproductive function (patient interview)</measure>
    <time_frame>12, 24, 36 months</time_frame>
    <description>ability of a woman after receiving treatment for uterine fibroids can conceive and deliver a healthy baby</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3094</enrollment>
  <condition>Fibroids, Uterine</condition>
  <arm_group>
    <arm_group_label>Medical</arm_group_label>
    <description>Patients who receive medical therapy only for treatment of their uterine fibroids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Procedure</arm_group_label>
    <description>Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hysterectomy</intervention_name>
    <description>surgical removal of the uterus</description>
    <arm_group_label>Procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Uterine arterial embolization</intervention_name>
    <description>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.</description>
    <arm_group_label>Procedure</arm_group_label>
    <other_name>UAE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>myomectomy</intervention_name>
    <description>surgical procedure to remove uterine fibroids, but does not remove uterus</description>
    <arm_group_label>Procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medical Therapy</intervention_name>
    <description>treatment of uterine fibroids with only medications, no procedure or surgery is used</description>
    <arm_group_label>Medical</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endometrial ablation</intervention_name>
    <description>surgical procedure that destroys uterine lining via a telescope placed inside the uterus</description>
    <arm_group_label>Procedure</arm_group_label>
    <other_name>NovaSure, Her Option, HydroTherm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>magnetic resonance guided focused ultrasound</intervention_name>
    <description>procedure that destroys fibroids while inside an MRI machine</description>
    <arm_group_label>Procedure</arm_group_label>
    <other_name>MRgFUS, ExAblate; Sonalleve</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>radiofrequency ablation</intervention_name>
    <description>procedure that uses heat to destroy uterine fibroids</description>
    <arm_group_label>Procedure</arm_group_label>
    <other_name>Accessa</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood assay&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        10,000 patients diagnosed with UF between the ages of 18 and 54. Patients must have had a&#xD;
        menstrual period within the last 12 months. Source documentation of UF must include either&#xD;
        imaging or a pathology report.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of UF by imaging or pathology report within 2 years of enrollment&#xD;
             initiation.&#xD;
&#xD;
          -  Menstrual period within 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Post-menopausal&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  55 years old or older&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evan R Myers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Medical Centers</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniformed Services University of the Health Sciences</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Health Systems</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://compare-uf.org/</url>
    <description>COMPARE-UF Registry website</description>
  </link>
  <link>
    <url>https://www.pcori.org/research-results/2019/developing-methods-comparing-outcomes-across-patient-groups-observational</url>
    <description>Additional research study HSRP20194228 &quot;Methods for the Design and Conduct of Subgroup Analysis in Observational Studies&quot;</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>November 17, 2020</last_update_submitted>
  <last_update_submitted_qc>November 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02260752
org study id: Pro00057883
secondary id: RFA-HS-14-006
nct id: NCT02260752
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: change in symptom relief (patient interview)
time frame: 12, 24, 36 months
description: degree to which bleeding and pain from uterine fibroids is alleviated
measure: change in preservation reproductive function (patient interview)
time frame: 12, 24, 36 months
description: ability of a woman after receiving treatment for uterine fibroids can conceive and deliver a healthy baby
arm group label: Medical
description: Patients who receive medical therapy only for treatment of their uterine fibroids
arm group label: Procedure
description: Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
intervention type: Procedure
intervention name: hysterectomy
description: surgical removal of the uterus
arm group label: Procedure
intervention type: Procedure
intervention name: Uterine arterial embolization
description: 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.
arm group label: Procedure
other name: UAE
intervention type: Procedure
intervention name: myomectomy
description: surgical procedure to remove uterine fibroids, but does not remove uterus
arm group label: Procedure
intervention type: Drug
intervention name: Medical Therapy
description: treatment of uterine fibroids with only medications, no procedure or surgery is used
arm group label: Medical
intervention type: Procedure
intervention name: endometrial ablation
description: surgical procedure that destroys uterine lining via a telescope placed inside the uterus
arm group label: Procedure
other name: NovaSure, Her Option, HydroTherm
intervention type: Procedure
intervention name: magnetic resonance guided focused ultrasound
description: procedure that destroys fibroids while inside an MRI machine
arm group label: Procedure
other name: MRgFUS, ExAblate; Sonalleve
intervention type: Procedure
intervention name: radiofrequency ablation
description: procedure that uses heat to destroy uterine fibroids
arm group label: Procedure
other name: Accessa
blood assay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 54 Years
healthy volunteers: No
last name: Evan R Myers, MD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://compare-uf.org/
description: COMPARE-UF Registry website
url: https://www.pcori.org/research-results/2019/developing-methods-comparing-outcomes-across-patient-groups-observational
description: Additional research study HSRP20194228 "Methods for the Design and Conduct of Subgroup Analysis in Observational Studies"
responsible party type: Sponsor
mesh term: Leiomyoma
mesh term: Myofibroma
sharing ipd: Yes