<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/NCT03748693</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-0073-18</org_study_id>
    <nct_id>NCT03748693</nct_id>
  </id_info>
  <brief_title>Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse</brief_title>
  <official_title>Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 aim of this study is to investigate the inflammatory and maturation processes of immature&#xD;
      myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP)&#xD;
      (stage III-IV) and in normal non-POP controls.&#xD;
&#xD;
      We hypothesize that the processes contributing to POP may be related to immune response and&#xD;
      changes in myeloid cell populations and the cytokine environment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Immune response in POP</measure>
    <time_frame>Two weeks</time_frame>
    <description>Tissue biopsy will analyzed for IMC and compared to control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cytokine environment in POP</measure>
    <time_frame>Two weeks</time_frame>
    <description>Tissue biopsy will analyzed for cytokine environment and compared to control group</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>POP Group</arm_group_label>
    <description>Women with POP undergoing surgery in our OB/GYN department.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-POP Group</arm_group_label>
    <description>Women undergoing hysterectomy for other indications.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hysterectomy</intervention_name>
    <description>Surgery performed on women with a variety of gynecological indications</description>
    <arm_group_label>Non-POP Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colporrhaphy</intervention_name>
    <description>Surgery performed on women with POP</description>
    <arm_group_label>POP Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women attending our OB/GYN department because of POP and other gynecological disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with POP undergoing colporrhaphy&#xD;
&#xD;
          -  Women undergoing hysterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Autoimmune and connective tissue disorders&#xD;
&#xD;
          -  Cancer in genital tract&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Mariana Ordonez, MD</last_name>
    <phone>972-52-3243474</phone>
    <email>malo_mariana@hotmail.com</email>
  </overall_contact>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</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>Inflammation</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</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/NCT03748693
org study id: HYMC-0073-18
nct id: NCT03748693
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the inflammatory and maturation processes of immature
      myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP)
      (stage III-IV) and in normal non-POP controls.

      We hypothesize that the processes contributing to POP may be related to immune response and
      changes in myeloid cell populations and the cytokine environment.
observational model: Case-Control
time perspective: Prospective
measure: Immune response in POP
time frame: Two weeks
description: Tissue biopsy will analyzed for IMC and compared to control group
measure: Cytokine environment in POP
time frame: Two weeks
description: Tissue biopsy will analyzed for cytokine environment and compared to control group
arm group label: POP Group
description: Women with POP undergoing surgery in our OB/GYN department.
arm group label: Non-POP Group
description: Women undergoing hysterectomy for other indications.
intervention type: Procedure
intervention name: Hysterectomy
description: Surgery performed on women with a variety of gynecological indications
arm group label: Non-POP Group
intervention type: Procedure
intervention name: Colporrhaphy
description: Surgery performed on women with POP
arm group label: POP Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 80 Years
last name: Mariana Ordonez, MD
phone: 972-52-3243474
email: malo_mariana@hotmail.com
responsible party type: Sponsor
mesh term: Inflammation
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No