<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/NCT02967068</url>
  </required_header>
  <id_info>
    <org_study_id>VCRC5511</org_study_id>
    <secondary_id>U54AR057319</secondary_id>
    <nct_id>NCT02967068</nct_id>
  </id_info>
  <brief_title>VCRC Tissue Repository</brief_title>
  <official_title>VCRC Tissue Biorepository Collection Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Office of Rare Diseases (ORD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect existing tissue specimens from subjects enrolled in&#xD;
      Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens&#xD;
      and linked clinical data collected through VCRC studies may lead to the identification and&#xD;
      development of a series of translational research projects. Results of these studies will&#xD;
      provide vasculitis researchers with insight into the causes of these diseases and generate&#xD;
      new ideas for diagnostic tests and therapies, and will be of great interest to the larger&#xD;
      communities of researchers investigating vasculitis and other autoimmune, inflammatory, and&#xD;
      vascular diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biopsy specimens collected as standard of care for these diseases will be retrieved and used&#xD;
      in research. The most common biopsies performed are kidney, lung, skin, nerves, and vessels;&#xD;
      however, other tissue is also of interest for the study. Biopsies are not performed as part&#xD;
      of this protocol, rather we will request consent to collect biopsy specimens already&#xD;
      collected under routine care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify genes that increase the risk of developing vasculitis</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluating of clinical data and linked biopsy specimens to identify genes that increase the risk of developing vasculitis.</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Aortitis</condition>
  <condition>Cutaneous Vasculitis</condition>
  <condition>Eosinophilic Granulomatosis With Polyangiitis</condition>
  <condition>Giant Cell Arteritis</condition>
  <condition>Granulomatosis With Polyangiitis (Wegener's)</condition>
  <condition>Henoch-Schonlein Purpura</condition>
  <condition>IgA Vasculitis</condition>
  <condition>Microscopic Polyangiitis</condition>
  <condition>Polyarteritis Nodosa</condition>
  <condition>Takayasu Arteritis</condition>
  <condition>Churg-Strauss Syndrome</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsy specimens collected as standard of care for these diseases will be retrieved and used&#xD;
      in research. The most common biopsies performed are kidney, lung, skin, nerves, and vessels.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 1000 patients with GCA, TAK, PAN, GPA, MPA, EGPA, cutaneous vasculitis and&#xD;
        aortitis will potentially be enrolled into the VCRC Tissue Biorepository Collection&#xD;
        Protocol.&#xD;
&#xD;
        The protocol will be conducted at the major vasculitis centers in the United States and&#xD;
        Canada participating in selected VCRC studies. Biopsy specimens collected as standard of&#xD;
        care for these diseases will be retrieved and used in research.&#xD;
&#xD;
        Biopsies are not performed as part of this protocol, rather we will request consent to&#xD;
        collect biopsy specimens already collected under routine care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A participant will be deemed eligible for this study if the participant is/was&#xD;
             enrolled in another one of the VCRC observational/longitudinal protocols (5502, 5503,&#xD;
             5504, 5505, 5506, 5507, 5563) and/or one of the VCRC interventional studies (5522,&#xD;
             5523, 5526, 5527, or 5562).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent (or their guardians in the case of children) and to&#xD;
             sign the consent form.&#xD;
&#xD;
          -  Unwilling to allow the use of their tissue for research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter A Merkel, MD, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherry Xu</last_name>
    <email>sherryxu@pennmedicine.upenn.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Boston University School of Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Minnie Singh</last_name>
      <email>SINGHN4@ccf.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherry Xu</last_name>
      <email>sherryxu@pennmedicine.upenn.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3B6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Messier</last_name>
      <email>smessier@stjoes.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Toronto Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suneet Khurana</last_name>
      <email>suneet.khurana@sinaihealth.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://rarediseasesnetwork.org/vcrc/</url>
    <description>Vasculitis Clinical Research Consortium</description>
  </link>
  <link>
    <url>http://rarediseasesnetwork.org</url>
    <description>Rare Diseases Clinical Research Network</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Peter Merkel</investigator_full_name>
    <investigator_title>Chief, Division of Rheumatology Professor of Medicine and Epidemiology</investigator_title>
  </responsible_party>
  <keyword>CSS</keyword>
  <keyword>EGPA</keyword>
  <keyword>GCA</keyword>
  <keyword>GPA</keyword>
  <keyword>MPA</keyword>
  <keyword>PAN</keyword>
  <keyword>TAK</keyword>
  <keyword>HSP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polymyalgia Rheumatica</mesh_term>
    <mesh_term>Granulomatosis with Polyangiitis</mesh_term>
    <mesh_term>Giant Cell Arteritis</mesh_term>
    <mesh_term>Microscopic Polyangiitis</mesh_term>
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Arteritis</mesh_term>
    <mesh_term>Systemic Vasculitis</mesh_term>
    <mesh_term>Takayasu Arteritis</mesh_term>
    <mesh_term>Aortic Arch Syndromes</mesh_term>
    <mesh_term>IgA Vasculitis</mesh_term>
    <mesh_term>Churg-Strauss Syndrome</mesh_term>
    <mesh_term>Polyarteritis Nodosa</mesh_term>
    <mesh_term>Aortitis</mesh_term>
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Skin Diseases, Vascular</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/NCT02967068
org study id: VCRC5511
secondary id: U54AR057319
nct id: NCT02967068
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to collect existing tissue specimens from subjects enrolled in
      Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens
      and linked clinical data collected through VCRC studies may lead to the identification and
      development of a series of translational research projects. Results of these studies will
      provide vasculitis researchers with insight into the causes of these diseases and generate
      new ideas for diagnostic tests and therapies, and will be of great interest to the larger
      communities of researchers investigating vasculitis and other autoimmune, inflammatory, and
      vascular diseases.
Biopsy specimens collected as standard of care for these diseases will be retrieved and used
      in research. The most common biopsies performed are kidney, lung, skin, nerves, and vessels;
      however, other tissue is also of interest for the study. Biopsies are not performed as part
      of this protocol, rather we will request consent to collect biopsy specimens already
      collected under routine care.
observational model: Cohort
time perspective: Other
measure: Identify genes that increase the risk of developing vasculitis
time frame: 1 year
description: Evaluating of clinical data and linked biopsy specimens to identify genes that increase the risk of developing vasculitis.
Biopsy specimens collected as standard of care for these diseases will be retrieved and used
      in research. The most common biopsies performed are kidney, lung, skin, nerves, and vessels.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Peter A Merkel, MD, MPH
role: Study Chair
affiliation: University of Pennsylvania
last name: Sherry Xu
email: sherryxu@pennmedicine.upenn.edu
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Canada
country: United States
url: http://rarediseasesnetwork.org/vcrc/
description: Vasculitis Clinical Research Consortium
url: http://rarediseasesnetwork.org
description: Rare Diseases Clinical Research Network
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Peter Merkel
investigator title: Chief, Division of Rheumatology Professor of Medicine and Epidemiology
mesh term: Polymyalgia Rheumatica
mesh term: Granulomatosis with Polyangiitis
mesh term: Giant Cell Arteritis
mesh term: Microscopic Polyangiitis
mesh term: Vasculitis
mesh term: Arteritis
mesh term: Systemic Vasculitis
mesh term: Takayasu Arteritis
mesh term: Aortic Arch Syndromes
mesh term: IgA Vasculitis
mesh term: Churg-Strauss Syndrome
mesh term: Polyarteritis Nodosa
mesh term: Aortitis
mesh term: Purpura
mesh term: Skin Diseases, Vascular
sharing ipd: No