<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/NCT04440397</url>
  </required_header>
  <id_info>
    <org_study_id>xbpendo</org_study_id>
    <nct_id>NCT04440397</nct_id>
  </id_info>
  <brief_title>Relationship Between Endoplasmic Reticulum Stress and Pain in Patients With Endometriosis</brief_title>
  <official_title>Endoplasmic Reticulum Stress and Endometriosis Releated Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</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>
      The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic&#xD;
      pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed&#xD;
      with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients.&#xD;
      XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain&#xD;
      pathogenesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and&#xD;
      ultrasound, without known rheumatological or metabolic diseases were included in the study.&#xD;
      Most of the patients are composed of newly diagnosed patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 17, 2020</start_date>
  <completion_date type="Actual">August 4, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the correlations between the results of XBP-1 levels and the stages and pain symptoms of endometriosis.</measure>
    <time_frame>5 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum XBP-1levels in patients wit endometriosis</measure>
    <time_frame>5 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">86</enrollment>
  <condition>Endometriosis</condition>
  <condition>Endoplasmic Reticulum Stress</condition>
  <condition>Endometriosis-related Pain</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>xbp-1 - endometriosis patients group</intervention_name>
    <description>Patients diagnosed with endometriosis by surgery and ultrasound and whose xbp-1 level was examined</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women between the ages of 18-50 who were diagnosed with endometriosis by ultrasound or&#xD;
        surgery and who did not have any rheumatological and metaboli disease were included in the&#xD;
        study. women with drug use indicated in the last 3 months were excluded from the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed endometriosis with ultrasound or surgery&#xD;
&#xD;
          -  no metabolic diseases&#xD;
&#xD;
          -  no rheumatological diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immune modulator, hormonal, anti-inflammatory use history in the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pinar Yalcin Bahat</name>
      <address>
        <city>Istanbul</city>
        <state>İ̇stanbul</state>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Pınar Yalcin bahat</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>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/NCT04440397
org study id: xbpendo
nct id: NCT04440397
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic
      pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed
      with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients.
      XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain
      pathogenesis.
Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and
      ultrasound, without known rheumatological or metabolic diseases were included in the study.
      Most of the patients are composed of newly diagnosed patients.
observational model: Case-Control
time perspective: Prospective
measure: Evaluation of the correlations between the results of XBP-1 levels and the stages and pain symptoms of endometriosis.
time frame: 5 months
measure: serum XBP-1levels in patients wit endometriosis
time frame: 5 months
intervention type: Other
intervention name: xbp-1 - endometriosis patients group
description: Patients diagnosed with endometriosis by surgery and ultrasound and whose xbp-1 level was examined
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Pınar Yalcin bahat
investigator title: Principal Investigator
mesh term: Endometriosis
sharing ipd: Yes