<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/NCT02983253</url>
  </required_header>
  <id_info>
    <org_study_id>ImmunUHEssen</org_study_id>
    <nct_id>NCT02983253</nct_id>
  </id_info>
  <brief_title>Immunmodulation in Patients With HHT</brief_title>
  <official_title>Immunmodulation in Patients With HHT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Essen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an&#xD;
      inherited multisystemic disorder. Literature suggests that HHT is often associated with&#xD;
      higher frequency of infectious diseases.&#xD;
&#xD;
      The purpose of this study is to evaluate a variety of immunologic parameters in the blood&#xD;
      serum of HHT patients in comparison to probands.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an&#xD;
      inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and&#xD;
      visceral arteriovenous malformations. Literature and the investigators' observation suggest&#xD;
      that HHT is often associated with higher frequency of infectious diseases. This might be a&#xD;
      hint for a immunocompromised situation.&#xD;
&#xD;
      The purpose of this study is to evaluate a variety of immunologic parameters in the blood&#xD;
      serum of HHT patients in comparison to probands.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Amounts of leucocytes in patients with HHT</measure>
    <time_frame>November 2016 - December 2018</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in distribution of leucocytes in patients with HHT</measure>
    <time_frame>November 2016 - December 2018</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional properties of leucocytes in patients with HHT</measure>
    <time_frame>November 2016 - December 2018</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Differences in size of leucocytes in patients with HHT</measure>
    <time_frame>November 2016 - December 2018</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">124</enrollment>
  <condition>Hereditary Haemorrhagic Telangiectasia (HHT)</condition>
  <arm_group>
    <arm_group_label>Patients with HHT</arm_group_label>
    <description>blood sample of patients with HHT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>probands</arm_group_label>
    <description>blood sample of healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sample</intervention_name>
    <description>none, only laboratory tests on blood serum</description>
    <arm_group_label>Patients with HHT</arm_group_label>
    <arm_group_label>probands</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion Criteria: Aged 18 or over, HHT,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18 or over, HHT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urban Geisthoff, Prof.Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Essen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 18, 2019</last_update_submitted>
  <last_update_submitted_qc>December 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Essen</investigator_affiliation>
    <investigator_full_name>Urban Geisthoff</investigator_full_name>
    <investigator_title>Prof. Dr. med. Urban Geisthoff</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Telangiectasis</mesh_term>
    <mesh_term>Telangiectasia, Hereditary Hemorrhagic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02983253
org study id: ImmunUHEssen
nct id: NCT02983253
lead sponsor: 
has dmc: No
Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an
      inherited multisystemic disorder. Literature suggests that HHT is often associated with
      higher frequency of infectious diseases.

      The purpose of this study is to evaluate a variety of immunologic parameters in the blood
      serum of HHT patients in comparison to probands.
Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an
      inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and
      visceral arteriovenous malformations. Literature and the investigators' observation suggest
      that HHT is often associated with higher frequency of infectious diseases. This might be a
      hint for a immunocompromised situation.

      The purpose of this study is to evaluate a variety of immunologic parameters in the blood
      serum of HHT patients in comparison to probands.
observational model: Cohort
time perspective: Cross-Sectional
measure: Amounts of leucocytes in patients with HHT
time frame: November 2016 - December 2018
measure: Differences in distribution of leucocytes in patients with HHT
time frame: November 2016 - December 2018
measure: Functional properties of leucocytes in patients with HHT
time frame: November 2016 - December 2018
measure: Differences in size of leucocytes in patients with HHT
time frame: November 2016 - December 2018
arm group label: Patients with HHT
description: blood sample of patients with HHT
arm group label: probands
description: blood sample of healthy controls
intervention type: Other
intervention name: blood sample
description: none, only laboratory tests on blood serum
arm group label: Patients with HHT
arm group label: probands
blood sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Urban Geisthoff, Prof.Dr.med.
role: Principal Investigator
affiliation: University Hospital, Essen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Essen
investigator full name: Urban Geisthoff
investigator title: Prof. Dr. med. Urban Geisthoff
mesh term: Telangiectasis
mesh term: Telangiectasia, Hereditary Hemorrhagic
sharing ipd: Undecided