<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/NCT03004326</url>
  </required_header>
  <id_info>
    <org_study_id>VCRC5563</org_study_id>
    <secondary_id>U54AR057319</secondary_id>
    <nct_id>NCT03004326</nct_id>
  </id_info>
  <brief_title>Clinical Transcriptomics in Systemic Vasculitis (CUTIS)</brief_title>
  <acronym>CUTIS</acronym>
  <official_title>Clinical Transcriptomics in Systemic Vasculitis (CUTIS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peter Merkel</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 Research (ORDR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multi-center observational study to evaluate the histopathology and transcriptome of&#xD;
      cutaneous lesions in patients with several different types of vasculitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study employs a multi-center approach to evaluate cutaneous vasculitis across several&#xD;
      forms of idiopathic vasculitis. Patients with cutaneous manifestations of vasculitis will be&#xD;
      evaluated by teams of primary vasculitis care providers and Dermatologists in order to&#xD;
      facilitate optimal selection of patients and sampling of lesions.&#xD;
&#xD;
      A punch skin biopsy at a site of active vasculitis will be the source of material for&#xD;
      histopathologic and transcriptomic evaluation. The histopathology of cutaneous vasculitis&#xD;
      will be characterized using a standardized approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Evaluation of clinical data and linked biopsy specimens</measure>
    <time_frame>1 year</time_frame>
    <description>Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cryoglobulinemic Vasculitis (CV)</condition>
  <condition>Drug-induced Vasculitis</condition>
  <condition>Eosinophilic Granulomatosis With Polyangiitis (EGPA)</condition>
  <condition>IgA Vasculitis</condition>
  <condition>Isolated Cutaneous Vasculitis</condition>
  <condition>Granulomatosis With Polyangiitis (GPA)</condition>
  <condition>Microscopic Polyangiitis (MPA)</condition>
  <condition>Polyarteritis Nodosa (PAN)</condition>
  <condition>Urticarial Vasculitis</condition>
  <condition>Vasculitis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be collected solely for research purposes. The reason we are performing&#xD;
      these laboratory-based research studies is to help us better understand whether abnormalities&#xD;
      detected in a subjects skin biopsy can also be detected in their blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        About 56 people with vasculitis will take part in this study at approximately 20 medical&#xD;
        centers across North America. Patients with CV, DiV, EGPA, IgA vasculitis, GPA, MPA, PAN,&#xD;
        isolated cutaneous vasculitis and urticarial vasculitis will potentially be enrolled into&#xD;
        this study.&#xD;
&#xD;
        The protocol will be conducted at the major vasculitis centers in the United States and&#xD;
        Canada participating in selected VCRC studies. Skin biopsy specimens collected as standard&#xD;
        of care for these diseases will be retrieved and used in research.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura,&#xD;
             nodules, ulcers, or urticarial) believed to be related to active vasculitis&#xD;
&#xD;
          -  Have a suspected or confirmed diagnosis of:&#xD;
&#xD;
               -  Cryoglobulinemic vasculitis (CV)&#xD;
&#xD;
               -  Drug-induced vasculitis&#xD;
&#xD;
               -  Eosinophilic granulomatosis with polyangiitis (EGPA)&#xD;
&#xD;
               -  IgA vasculitis&#xD;
&#xD;
               -  Isolated cutaneous vasculitis&#xD;
&#xD;
               -  Granulomatosis with polyangiitis (GPA)&#xD;
&#xD;
               -  Microscopic polyangiitis (MPA)&#xD;
&#xD;
               -  Polyarteritis nodosa (PAN)&#xD;
&#xD;
               -  Urticarial vasculitis&#xD;
&#xD;
          -  Be willing and able to provide written informed consent (or assent for those under&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  You are less than five years old&#xD;
&#xD;
          -  Considered not to be a candidate for a biopsy or have a higher risk of developing an&#xD;
             infection, bleeding, etc., from the biopsy, or a doctor believes that the risks for&#xD;
             you participating in this study do not outweigh the potential benefit of learning&#xD;
             information from your biopsy&#xD;
&#xD;
          -  You have a neutrophil count (type of white blood cell) less than 1500/mm3, platelet&#xD;
             count less than 50,000/mm3, or a hemoglobin less than 7 g/dL&#xD;
&#xD;
          -  You have an uncontrolled disease that could prevent you from completing the study&#xD;
             procedures&#xD;
&#xD;
          -  You have an active infection at or near the potential biopsy site, have poor&#xD;
             circulation, or have bony prominence or other structure that would increase your risk&#xD;
             of complications if you participated in this study&#xD;
&#xD;
          -  You are pregnant or nursing&#xD;
&#xD;
          -  You are not able to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Micheletti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Grayson, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The National Institute of Arthritis and Musculoskeletal and Skin Diseases</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carol McAlear, MA</last_name>
    <email>cmcalear@upenn.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tandy Ramirez</last_name>
      <email>ItandewyRamirez@mednet.ucla.edu</email>
    </contact>
  </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>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</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>Completed</status>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </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>Josh Bryer</last_name>
      <email>jbryer@pennmedicine.upenn.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </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://www.rarediseasesnetwork.org/vcrc</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 20, 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>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>DIV</keyword>
  <keyword>CSS</keyword>
  <keyword>EGPA</keyword>
  <keyword>HSP</keyword>
  <keyword>GPA</keyword>
  <keyword>MPA</keyword>
  <keyword>PAN</keyword>
  <keyword>Wegeners</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Granulomatosis with Polyangiitis</mesh_term>
    <mesh_term>Microscopic Polyangiitis</mesh_term>
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Systemic Vasculitis</mesh_term>
    <mesh_term>Churg-Strauss Syndrome</mesh_term>
    <mesh_term>Polyarteritis Nodosa</mesh_term>
    <mesh_term>IgA Vasculitis</mesh_term>
    <mesh_term>Skin Diseases, Vascular</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/NCT03004326
org study id: VCRC5563
secondary id: U54AR057319
nct id: NCT03004326
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Multi-center observational study to evaluate the histopathology and transcriptome of
      cutaneous lesions in patients with several different types of vasculitis.
This study employs a multi-center approach to evaluate cutaneous vasculitis across several
      forms of idiopathic vasculitis. Patients with cutaneous manifestations of vasculitis will be
      evaluated by teams of primary vasculitis care providers and Dermatologists in order to
      facilitate optimal selection of patients and sampling of lesions.

      A punch skin biopsy at a site of active vasculitis will be the source of material for
      histopathologic and transcriptomic evaluation. The histopathology of cutaneous vasculitis
      will be characterized using a standardized approach.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of clinical data and linked biopsy specimens
time frame: 1 year
description: Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.
Blood samples will be collected solely for research purposes. The reason we are performing
      these laboratory-based research studies is to help us better understand whether abnormalities
      detected in a subjects skin biopsy can also be detected in their blood.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Micheletti, MD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Peter Grayson, MD, MSc
role: Principal Investigator
affiliation: The National Institute of Arthritis and Musculoskeletal and Skin Diseases
last name: Carol McAlear, MA
email: cmcalear@upenn.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
country: Canada
country: United States
url: http://www.rarediseasesnetwork.org/vcrc
description: Related Info
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Peter Merkel
investigator title: Chief, Division of Rheumatology Professor of Medicine and Epidemiology
mesh term: Granulomatosis with Polyangiitis
mesh term: Microscopic Polyangiitis
mesh term: Vasculitis
mesh term: Systemic Vasculitis
mesh term: Churg-Strauss Syndrome
mesh term: Polyarteritis Nodosa
mesh term: IgA Vasculitis
mesh term: Skin Diseases, Vascular