<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/NCT02190942</url>
  </required_header>
  <id_info>
    <org_study_id>5535</org_study_id>
    <nct_id>NCT02190942</nct_id>
  </id_info>
  <brief_title>VCRC Patient Contact Registry Patient-Reported Data Validation Study</brief_title>
  <official_title>VCRC Validation of Patient-Reported Diagnostic Data</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to provide validation of patient-reported data in the VCRC&#xD;
      Patient Contact Registry by comparing patient-reported data with data provided by the&#xD;
      physician who is the primary provider caring for the patient's vasculitis. Patients enrolled&#xD;
      in the Patient Contact Registry with Behcet's disease, eosinophilic granulomatosis with&#xD;
      polyangiitis (Churg-Strauss) (EGPA), giant cell arteritis (GCA), granulomatosis with&#xD;
      polyangiitis (Wegener's) (GPA), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN),&#xD;
      and Takayasu's arteritis (TAK) were invited via email to participate in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Via email, consent was obtained from at least 20 randomly selected patients with the seven&#xD;
      forms of vasculitis detailed above in the VCRC Patient Contact Registry who have completed&#xD;
      the Diagnostic Questionnaire. The form was sent in PDF format to the patient, who either&#xD;
      printed out or emailed the form to his or her primary vasculitis provider to complete. This&#xD;
      form included the same questions in the patient questionnaire, with minor reformatting and a&#xD;
      few expanded details to verify the patient-provided data (please see appendix B). If the 20&#xD;
      questionnaires are not returned one month after the initial recruitment email to the Patient&#xD;
      Contact Registry participants, 20 additional participants with the seven forms of vasculitis&#xD;
      will be selected randomly and will be asked to participate in this study. The survey data is&#xD;
      stored by the Rare Diseases Clinical Research Network's (RDCRN) Data Management and&#xD;
      Coordinating Center (DMCC) at the University of South Florida. The data is de-identified.&#xD;
      Names or other personal health information were not collected. Upon conclusion of the study&#xD;
      period, the data will be sent to Dr. Kathleen McKinnon. All data collected will be sent to&#xD;
      the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">June 18, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Validation of the currently utilized VCRC Patient Contact Registry Questionnaire</measure>
    <time_frame>Up to 24 months from the date of the last patient assessment</time_frame>
    <description>The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate diagnostic accuracy of specific questions</measure>
    <time_frame>Up to 24 months form the last patient assessment received</time_frame>
    <description>The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">198</enrollment>
  <condition>Behcet's Disease</condition>
  <condition>Churg-Strauss Syndrome</condition>
  <condition>Giant Cell Arteritis</condition>
  <condition>Wegener Granulomatosis</condition>
  <condition>Microscopic Polyangiitis</condition>
  <condition>Polyarteritis Nodosa</condition>
  <condition>Takayasu's Arteritis</condition>
  <arm_group>
    <arm_group_label>Vasculitis Contact Registry Patients</arm_group_label>
    <description>Consent will be obtained from at least 20 randomly selected patients with each of the following self-identified diagnoses in the VCRC Patient Contact Registry: Behçet's disease, EGPA, GCA, GPA, MPA, PAN and TAK that have already completed the VCRC Diagnostic Questionnaires. Permission will be obtained to contact subjects' primary vasculitis care providers to request that the providers complete an online version of this questionnaire (or print copy, if they prefer), and request specific chart items from their office to further verify the data.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consent will be obtained from at least 20 randomly selected patients with each of the&#xD;
        following self-identified diagnoses in the VCRC Patient Contact Registry: Behçet's disease,&#xD;
        EGPA, GCA, GPA, MPA, PAN and TAK that have already completed the VCRC Diagnostic&#xD;
        Questionnaires. Permission will be obtained to contact subjects' primary vasculitis care&#xD;
        providers to request that the providers complete an online version of this questionnaire&#xD;
        (or print copy, if they prefer), and request specific chart items from their office to&#xD;
        further verify the data. The sensitivity and specificity for various combinations of the&#xD;
        diagnostic questions to predict vasculitis and to confirm type of vasculitis will be&#xD;
        calculated using physician diagnosis / chart review as the gold standard.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 20 patients with each of the following self-identified diagnoses in the VCRC&#xD;
             Patient Contact Registry: Behçet's disease, EGPA, GCA, GPA, MPA, PAN, and TAK who have&#xD;
             completed the online questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent and complete survey&#xD;
&#xD;
          -  Patients whose diagnosis of vasculitis was not confirmed by a physician&#xD;
&#xD;
          -  Patients who did not complete the initial questionnaire in its entirety&#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>Kathleen McKinnon, DO</last_name>
    <role>Study Chair</role>
    <affiliation>Henry Ford/Wayne State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ximena D. Ruiz, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter A. Merkel, MD, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer L. Harris, MSPH, CCRP</last_name>
    <role>Study Chair</role>
    <affiliation>University of South Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Florida Data Management Coordinating Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>May 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polymyalgia Rheumatica</mesh_term>
    <mesh_term>Behcet Syndrome</mesh_term>
    <mesh_term>Granulomatosis with Polyangiitis</mesh_term>
    <mesh_term>Giant Cell Arteritis</mesh_term>
    <mesh_term>Microscopic Polyangiitis</mesh_term>
    <mesh_term>Arteritis</mesh_term>
    <mesh_term>Takayasu Arteritis</mesh_term>
    <mesh_term>Aortic Arch Syndromes</mesh_term>
    <mesh_term>Churg-Strauss Syndrome</mesh_term>
    <mesh_term>Polyarteritis Nodosa</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/NCT02190942
org study id: 5535
nct id: NCT02190942
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to provide validation of patient-reported data in the VCRC
      Patient Contact Registry by comparing patient-reported data with data provided by the
      physician who is the primary provider caring for the patient's vasculitis. Patients enrolled
      in the Patient Contact Registry with Behcet's disease, eosinophilic granulomatosis with
      polyangiitis (Churg-Strauss) (EGPA), giant cell arteritis (GCA), granulomatosis with
      polyangiitis (Wegener's) (GPA), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN),
      and Takayasu's arteritis (TAK) were invited via email to participate in this study.
Via email, consent was obtained from at least 20 randomly selected patients with the seven
      forms of vasculitis detailed above in the VCRC Patient Contact Registry who have completed
      the Diagnostic Questionnaire. The form was sent in PDF format to the patient, who either
      printed out or emailed the form to his or her primary vasculitis provider to complete. This
      form included the same questions in the patient questionnaire, with minor reformatting and a
      few expanded details to verify the patient-provided data (please see appendix B). If the 20
      questionnaires are not returned one month after the initial recruitment email to the Patient
      Contact Registry participants, 20 additional participants with the seven forms of vasculitis
      will be selected randomly and will be asked to participate in this study. The survey data is
      stored by the Rare Diseases Clinical Research Network's (RDCRN) Data Management and
      Coordinating Center (DMCC) at the University of South Florida. The data is de-identified.
      Names or other personal health information were not collected. Upon conclusion of the study
      period, the data will be sent to Dr. Kathleen McKinnon. All data collected will be sent to
      the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely.
observational model: Cohort
time perspective: Cross-Sectional
measure: Validation of the currently utilized VCRC Patient Contact Registry Questionnaire
time frame: Up to 24 months from the date of the last patient assessment
description: The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.
measure: Evaluate diagnostic accuracy of specific questions
time frame: Up to 24 months form the last patient assessment received
description: The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.
arm group label: Vasculitis Contact Registry Patients
description: Consent will be obtained from at least 20 randomly selected patients with each of the following self-identified diagnoses in the VCRC Patient Contact Registry: Behçet's disease, EGPA, GCA, GPA, MPA, PAN and TAK that have already completed the VCRC Diagnostic Questionnaires. Permission will be obtained to contact subjects' primary vasculitis care providers to request that the providers complete an online version of this questionnaire (or print copy, if they prefer), and request specific chart items from their office to further verify the data.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kathleen McKinnon, DO
role: Study Chair
affiliation: Henry Ford/Wayne State University
last name: Ximena D. Ruiz, MD
role: Study Chair
affiliation: University of Pittsburgh
last name: Peter A. Merkel, MD, MPH
role: Study Chair
affiliation: University of Pennsylvania
last name: Jennifer L. Harris, MSPH, CCRP
role: Study Chair
affiliation: University of South Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Polymyalgia Rheumatica
mesh term: Behcet Syndrome
mesh term: Granulomatosis with Polyangiitis
mesh term: Giant Cell Arteritis
mesh term: Microscopic Polyangiitis
mesh term: Arteritis
mesh term: Takayasu Arteritis
mesh term: Aortic Arch Syndromes
mesh term: Churg-Strauss Syndrome
mesh term: Polyarteritis Nodosa