<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/NCT03022331</url>
  </required_header>
  <id_info>
    <org_study_id>VCRC5507</org_study_id>
    <secondary_id>U54AR057319</secondary_id>
    <nct_id>NCT03022331</nct_id>
  </id_info>
  <brief_title>VCRC Longitudinal Protocol for Aortitis</brief_title>
  <official_title>VCRC Longitudinal Protocol for Aortitis</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>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The term 'aortitis' refers to inflammation of the aorta. Aortitis is known to occur in a&#xD;
      variety of vasculitides and connective tissue diseases, such as giant cell arteritis (GCA),&#xD;
      Takayasu arteritis (TAK), rheumatoid arthritis, and spondyloarthropathies, among others. This&#xD;
      study will establish a longitudinal cohort for these diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will develop a longitudinal cohort of patients with different types of aortitis to&#xD;
      systematically study the natural history, optimal treatments, and outcomes in this group of&#xD;
      diseases. This will provide a resource for future studies and for identification of new&#xD;
      biomarkers of aortitis for purposes of diagnosis, disease activity measurement, disease&#xD;
      damage assessment, determination of disease states, and evaluation of treatment response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Phenotypic correlates of genotype</measure>
    <time_frame>5 years</time_frame>
    <description>Using longitudinally collected phenotypic data, this project aims to define the natural history (i.e. biochemical evidence of systemic inflammation, and systemic symptoms) of different types of phenotypes of aortitis and related disorders in patients using serum and genetic information collected through specimens.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Aortitis</condition>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and urine samples, including genetic information (DNA), will be collected from patients&#xD;
      with aortitis in this study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 250 patients with aortitis will be enrolled into the VCRC longitudinal&#xD;
        observational cohort study and followed for up to ten years. The study will be conducted at&#xD;
        major vasculitis centers in North America, utilizing the Clinical and Translational Science&#xD;
        Center (CTSC) at each site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects will be included if they meet one of the following criteria:&#xD;
&#xD;
          1. Previous or current microscopic evidence of aortitis (active or healed) on surgical&#xD;
             specimen obtained during aortic resection&#xD;
&#xD;
          2. Previous or current radiographic aortitis that could include circumferential aortic&#xD;
             wall thickening of at least 3mm on CT or MRI or increased PET FDG uptake in the aorta&#xD;
             at values equal to or greater than the liver, in absence of an alternative explanation&#xD;
             for the radiographic findings.&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          1. Subjects already enrolled in one of the other VCRC longitudinal cohorts: 5502, 5503,&#xD;
             5504, 5505, and 5506.&#xD;
&#xD;
          2. Inability of participants (or their guardians in the case of children) to give&#xD;
             informed consent and to sign the consent form.&#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>Nataliya Milman, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ottawa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter A Merkel, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <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>
  </location>
  <location>
    <facility>
      <name>Boston University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University British Columbia/Mary Pack Arthritis Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L9C 0E3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toronto, Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </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>May 2020</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>May 7, 2020</last_update_submitted>
  <last_update_submitted_qc>May 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2020</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>Idiopathic aortitis</keyword>
  <keyword>Isolated aortitis</keyword>
  <keyword>Vasculitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortitis</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/NCT03022331
org study id: VCRC5507
secondary id: U54AR057319
nct id: NCT03022331
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The term 'aortitis' refers to inflammation of the aorta. Aortitis is known to occur in a
      variety of vasculitides and connective tissue diseases, such as giant cell arteritis (GCA),
      Takayasu arteritis (TAK), rheumatoid arthritis, and spondyloarthropathies, among others. This
      study will establish a longitudinal cohort for these diseases.
This study will develop a longitudinal cohort of patients with different types of aortitis to
      systematically study the natural history, optimal treatments, and outcomes in this group of
      diseases. This will provide a resource for future studies and for identification of new
      biomarkers of aortitis for purposes of diagnosis, disease activity measurement, disease
      damage assessment, determination of disease states, and evaluation of treatment response.
observational model: Cohort
time perspective: Prospective
measure: Phenotypic correlates of genotype
time frame: 5 years
description: Using longitudinally collected phenotypic data, this project aims to define the natural history (i.e. biochemical evidence of systemic inflammation, and systemic symptoms) of different types of phenotypes of aortitis and related disorders in patients using serum and genetic information collected through specimens.
arm group label: Observational
Blood and urine samples, including genetic information (DNA), will be collected from patients
      with aortitis in this study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Nataliya Milman, MD, MSc
role: Principal Investigator
affiliation: University of Ottawa
last name: Peter A Merkel, MD, MPH
role: Study Director
affiliation: University of Pennsylvania
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
url: http://www.rarediseasesnetwork.org/vcrc
description: Related Info
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: Aortitis