<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/NCT02247622</url>
  </required_header>
  <id_info>
    <org_study_id>1.1</org_study_id>
    <nct_id>NCT02247622</nct_id>
  </id_info>
  <brief_title>Telomere Length and Other Parameters of Telomere Dysfunction in PSC and Colitis</brief_title>
  <official_title>Primary Sclerosing Cholangitis Telomere Length</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PSC is a chronic cholestatic disorder. The investigators intend to study some telomere&#xD;
      parameters and telomere length in order to predict a premalignant state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary sclerosing cholangitis (PSC) and colitis are chronic inflammatory disorders with&#xD;
      malignant potential. Telomerase is an enzyme complex that lengthens telomeres and has&#xD;
      enhanced expression in numerous malignancies. In this study, we evaluated the telomerase gene&#xD;
      copy number, telomere length, cells in senescence, aneuploidy and additional parameters of&#xD;
      telomere dysfunction from peripheral blood lymphocytes of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Telomere length</measure>
    <time_frame>1.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of cells with increased telomerase RNA component (TERC) expression</measure>
    <time_frame>1.5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Primary Sclerosing Cholangitis</condition>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>IBD</arm_group_label>
    <description>patients with inflammatory bowel disease, study group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PSC</arm_group_label>
    <description>patients with primary sclerosing cholangitis, study group</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with primary sclerosing cholangitis and inflammatory bowel disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  documented PSC and inflammatory bowel disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years, above 80 y&#xD;
&#xD;
          -  known active malignancy&#xD;
&#xD;
          -  decompensated cirrhosis&#xD;
&#xD;
          -  patients who cannot sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ido Laish, MD</last_name>
    <phone>+972-549477261</phone>
    <email>ido.laish@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ido Laish, MD</last_name>
      <email>ido.laish@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Ido Laish, Md</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 10, 2013</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>ido laish</investigator_full_name>
    <investigator_title>Md.</investigator_title>
  </responsible_party>
  <keyword>telomeres</keyword>
  <keyword>PSC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Cholangitis, Sclerosing</mesh_term>
  </condition_browse>
  <!-- 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/NCT02247622
org study id: 1.1
nct id: NCT02247622
lead sponsor: 
has dmc: Yes
PSC is a chronic cholestatic disorder. The investigators intend to study some telomere
      parameters and telomere length in order to predict a premalignant state.
Primary sclerosing cholangitis (PSC) and colitis are chronic inflammatory disorders with
      malignant potential. Telomerase is an enzyme complex that lengthens telomeres and has
      enhanced expression in numerous malignancies. In this study, we evaluated the telomerase gene
      copy number, telomere length, cells in senescence, aneuploidy and additional parameters of
      telomere dysfunction from peripheral blood lymphocytes of patients.
observational model: Cohort
time perspective: Prospective
measure: Telomere length
time frame: 1.5 years
measure: number of cells with increased telomerase RNA component (TERC) expression
time frame: 1.5 years
arm group label: Healthy control
arm group label: IBD
description: patients with inflammatory bowel disease, study group
arm group label: PSC
description: patients with primary sclerosing cholangitis, study group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ido Laish, MD
phone: +972-549477261
email: ido.laish@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: ido laish
investigator title: Md.
mesh term: Inflammatory Bowel Diseases
mesh term: Cholangitis
mesh term: Cholangitis, Sclerosing