<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/NCT03003845</url>
  </required_header>
  <id_info>
    <org_study_id>27338</org_study_id>
    <nct_id>NCT03003845</nct_id>
  </id_info>
  <brief_title>S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain</brief_title>
  <acronym>S1P1</acronym>
  <official_title>Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain : Identification of Potential Relevant Biomarkers</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>
      For each patient in the study, blood, and pain scores will be collected to look for markers&#xD;
      for pain, at the start of treatment and 6 months after surgery of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is investigator-initiated, prospective, study. There will be no change in care.&#xD;
&#xD;
      Patients who have had a diagnosis of IC made by cystoscopy and hydrodistension and still have&#xD;
      pain will be recruited for this study.&#xD;
&#xD;
      Patients will have blood samples taken at the visit they sign the consent form and 6 months&#xD;
      later.&#xD;
&#xD;
      The study staff will call and remind the patient of their 6 month visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">February 27, 2020</completion_date>
  <primary_completion_date type="Actual">February 27, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Change From Baseline in Pain Scores on the Visual Analog Scale at 6 months</measure>
    <time_frame>3 months</time_frame>
    <description>S1PR1 levels in PBLs can discriminate patients with Interstitial Cystitis pain and patients with other types of pain.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Interstitial Cystitis</condition>
  <arm_group>
    <arm_group_label>Interstitial Cystitis</arm_group_label>
    <description>Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery</description>
    <arm_group_label>Interstitial Cystitis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collection of Blood samples</intervention_name>
    <description>Blood for PBLs will be collected at 3, 6, and 12 months post surgery</description>
    <arm_group_label>Interstitial Cystitis</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      PERIPHERAL BLOOD LEUKOCYTE (PBLS) ANALYSIS (Research Related):&#xD;
&#xD;
      Using immunoblotting, we will determine if the level of S1PR1 expression in peripheral blood&#xD;
      leukocytes (PBLs) is increased in patients with IC pain. Patients will have blood samples&#xD;
      taken, at the visit they sign the consent form 3 and 6 months later. A total of 4 teaspoons&#xD;
      of blood will be taken for the study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women are included. The onset of interstitial cystitis usually occurs between 30 and 70&#xD;
        years of age, with a median age of 43.&#xD;
&#xD;
        .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-70 years of age&#xD;
&#xD;
          -  Patients must be able to provide written informed consent.&#xD;
&#xD;
          -  Diagnosis of Interstitial Cystitis documented by provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 or &gt;70 years of age&#xD;
&#xD;
          -  pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugen C Campian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University Department of Obstetrics, Gynecology, and Women's Health</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>July 2021</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Eugen C. Campian, 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>Cystitis</mesh_term>
    <mesh_term>Cystitis, Interstitial</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/NCT03003845
org study id: 27338
nct id: NCT03003845
lead sponsor: 
has dmc: No
For each patient in the study, blood, and pain scores will be collected to look for markers
      for pain, at the start of treatment and 6 months after surgery of treatment.
The study is investigator-initiated, prospective, study. There will be no change in care.

      Patients who have had a diagnosis of IC made by cystoscopy and hydrodistension and still have
      pain will be recruited for this study.

      Patients will have blood samples taken at the visit they sign the consent form and 6 months
      later.

      The study staff will call and remind the patient of their 6 month visit.
observational model: Other
time perspective: Prospective
measure: Change From Baseline in Pain Scores on the Visual Analog Scale at 6 months
time frame: 3 months
description: S1PR1 levels in PBLs can discriminate patients with Interstitial Cystitis pain and patients with other types of pain.
arm group label: Interstitial Cystitis
description: Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months
intervention type: Other
intervention name: Questionnaires
description: QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery
arm group label: Interstitial Cystitis
intervention type: Other
intervention name: Collection of Blood samples
description: Blood for PBLs will be collected at 3, 6, and 12 months post surgery
arm group label: Interstitial Cystitis
PERIPHERAL BLOOD LEUKOCYTE (PBLS) ANALYSIS (Research Related):

      Using immunoblotting, we will determine if the level of S1PR1 expression in peripheral blood
      leukocytes (PBLs) is increased in patients with IC pain. Patients will have blood samples
      taken, at the visit they sign the consent form 3 and 6 months later. A total of 4 teaspoons
      of blood will be taken for the study.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Eugen C Campian, 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: Eugen C. Campian, MD
investigator title: Principal Investigator
mesh term: Cystitis
mesh term: Cystitis, Interstitial
sharing ipd: No