<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/NCT03002870</url>
  </required_header>
  <id_info>
    <org_study_id>20900</org_study_id>
    <nct_id>NCT03002870</nct_id>
  </id_info>
  <brief_title>Characteristics of Patient Population With Endometriosis</brief_title>
  <acronym>20900</acronym>
  <official_title>Characteristics of Patient Population With Endometriosis - A Prospective Database and BioBank</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect and analyze data on the characteristics of women who&#xD;
      are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as&#xD;
      part of their standard medical care. Data collected will contribute to the development of&#xD;
      guidelines for the surgical management of endometriosis. In addition, specimens will be&#xD;
      collected for future testing regarding diagnosing, and/or staging of endometriosis, or&#xD;
      suspected endometriosis, pain and infertility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients seen at Saint Louis University Center for Endometriosis (which has offices locations&#xD;
      at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system),&#xD;
      and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St.&#xD;
      Mary's hospital (only).&#xD;
&#xD;
      A preoperative questionnaire will be provided to the subject. Questions from the survey&#xD;
      include information on baseline demographics, severity and type of pain, and previous medical&#xD;
      and surgical history. Operative data will also be collected and analyzed.&#xD;
&#xD;
      A post-operative questionnaire will be administered to the participants at 6 months, and then&#xD;
      at regular yearly intervals after the surgery by a secure on-line process using the RedCap&#xD;
      software. Improvement in quality of life and pain scores will be analyzed.&#xD;
&#xD;
      Specimens will also be collected and stored for future testing regarding diagnosing, and/or&#xD;
      staging of endometriosis, suspected endometriosis, pain and infertility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life, pain and fertility</measure>
    <time_frame>every 12 months</time_frame>
    <description>(QOL) endometriosis health profile (EHP-5)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Endometriosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients whom pathology results post surgery document endometriosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Patients will receive questionnaires yearly to follow their QOL</description>
    <arm_group_label>Endometriosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients&#xD;
&#xD;
          -  13-55 years of age&#xD;
&#xD;
          -  Anyone seen at the Center for Endometriosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior bilateral salpingo-oophorectomy&#xD;
&#xD;
          -  post natural menopause&#xD;
&#xD;
          -  Significant mental or chronic systemic illness that might confound pain assessment or&#xD;
             the inability to complete the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Yeung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Patrick Yeung Jr., MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03002870
org study id: 20900
nct id: NCT03002870
lead sponsor: 
has dmc: No
The purpose of this study is to collect and analyze data on the characteristics of women who
      are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as
      part of their standard medical care. Data collected will contribute to the development of
      guidelines for the surgical management of endometriosis. In addition, specimens will be
      collected for future testing regarding diagnosing, and/or staging of endometriosis, or
      suspected endometriosis, pain and infertility.
Patients seen at Saint Louis University Center for Endometriosis (which has offices locations
      at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system),
      and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St.
      Mary's hospital (only).

      A preoperative questionnaire will be provided to the subject. Questions from the survey
      include information on baseline demographics, severity and type of pain, and previous medical
      and surgical history. Operative data will also be collected and analyzed.

      A post-operative questionnaire will be administered to the participants at 6 months, and then
      at regular yearly intervals after the surgery by a secure on-line process using the RedCap
      software. Improvement in quality of life and pain scores will be analyzed.

      Specimens will also be collected and stored for future testing regarding diagnosing, and/or
      staging of endometriosis, suspected endometriosis, pain and infertility.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of life, pain and fertility
time frame: every 12 months
description: (QOL) endometriosis health profile (EHP-5)
arm group label: Endometriosis
arm group type: Other
description: Patients whom pathology results post surgery document endometriosis
intervention type: Other
intervention name: Questionnaires
description: Patients will receive questionnaires yearly to follow their QOL
arm group label: Endometriosis
criteria: 
gender: Female
minimum age: 13 Years
maximum age: 55 Years
healthy volunteers: No
last name: Patrick Yeung, MD
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Patrick Yeung Jr., MD
investigator title: Principal Investigator
mesh term: Endometriosis
sharing ipd: No