<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/NCT02973854</url>
  </required_header>
  <id_info>
    <org_study_id>25996</org_study_id>
    <nct_id>NCT02973854</nct_id>
  </id_info>
  <brief_title>Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat</brief_title>
  <acronym>S1P1</acronym>
  <official_title>Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients seen at the SLUCare Center for Endometriosis (including those with or without pain)&#xD;
      undergoing laser excision surgery for known or suspected endometriosis will be recruited for&#xD;
      the study.&#xD;
&#xD;
      Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum&#xD;
      will be excised (removed).&#xD;
&#xD;
      After surgical excision has been performed, in order to provide standardized specimens for&#xD;
      our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3&#xD;
      mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue&#xD;
      will be sent to histology (SSM) for evaluation and classification as having endometriosis or&#xD;
      not. For each patient in the study, blood will also be collected to look for markers for&#xD;
      endometriosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is investigator-initiated, prospective, comparative study. Laparoscopic surgery for&#xD;
      endometriosis on patients presenting with pain, infertility or both will be performed by the&#xD;
      principal investigator at St. Mary's Hospital. We will be collecting preoperative, operative&#xD;
      and postoperative follow-up data on all patients recruited for this study based on&#xD;
      comprehensive preoperative questionnaires, which includes data collection on pain scores (by&#xD;
      VAS scales) and standardized QOL scales, and the 6-12 month follow questionnaire. The&#xD;
      surgical approach in the treatment of endometriosis is by excision only, so that all lesions&#xD;
      (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified&#xD;
      at a histologic level, which is the gold standard way to diagnose the presence of&#xD;
      endometriosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">September 10, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>S1PR1 levels in PBLs with and without endometriosis.</measure>
    <time_frame>At Surgery</time_frame>
    <description>To determine if S1PR1 levels in PBLs can discriminate between patients with endometriosis and patients without endometriosis.</description>
  </primary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Endometriosis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum&#xD;
      will be excised (removed).&#xD;
&#xD;
      After surgical excision has been performed, in order to provide standardized specimens for&#xD;
      our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3&#xD;
      mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue&#xD;
      will be sent to histology (SSM) for evaluation and classification as having endometriosis or&#xD;
      not. For each patient in the study, blood will also be collected to look for markers for&#xD;
      endometriosis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients seen at the Center for Endometriosis (including those with or without pain)&#xD;
        undergoing laser excision surgery for known or suspected endometriosis will be recruited&#xD;
        for the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients seen at the Center for Endometriosis (including those with or without pain)&#xD;
             who are undergoing excision surgery.&#xD;
&#xD;
          -  Patients who are undergoing laser excision surgery for known or suspected&#xD;
             endometriosis will be recruited for the study.&#xD;
&#xD;
          -  Completed a preoperative questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior bilateral salpingo-oophorectomy&#xD;
&#xD;
          -  post natural menopause&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SSM St. Mary's</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>September 2020</verification_date>
  <study_first_submitted>October 4, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</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>MD</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/NCT02973854
org study id: 25996
nct id: NCT02973854
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients seen at the SLUCare Center for Endometriosis (including those with or without pain)
      undergoing laser excision surgery for known or suspected endometriosis will be recruited for
      the study.

      Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum
      will be excised (removed).

      After surgical excision has been performed, in order to provide standardized specimens for
      our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3
      mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue
      will be sent to histology (SSM) for evaluation and classification as having endometriosis or
      not. For each patient in the study, blood will also be collected to look for markers for
      endometriosis.
The study is investigator-initiated, prospective, comparative study. Laparoscopic surgery for
      endometriosis on patients presenting with pain, infertility or both will be performed by the
      principal investigator at St. Mary's Hospital. We will be collecting preoperative, operative
      and postoperative follow-up data on all patients recruited for this study based on
      comprehensive preoperative questionnaires, which includes data collection on pain scores (by
      VAS scales) and standardized QOL scales, and the 6-12 month follow questionnaire. The
      surgical approach in the treatment of endometriosis is by excision only, so that all lesions
      (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified
      at a histologic level, which is the gold standard way to diagnose the presence of
      endometriosis.
observational model: Case-Only
time perspective: Prospective
measure: S1PR1 levels in PBLs with and without endometriosis.
time frame: At Surgery
description: To determine if S1PR1 levels in PBLs can discriminate between patients with endometriosis and patients without endometriosis.
Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum
      will be excised (removed).

      After surgical excision has been performed, in order to provide standardized specimens for
      our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3
      mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue
      will be sent to histology (SSM) for evaluation and classification as having endometriosis or
      not. For each patient in the study, blood will also be collected to look for markers for
      endometriosis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 13 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Patrick Yeung Jr., MD
investigator title: MD
mesh term: Endometriosis
sharing ipd: No