VCRC Patient Contact Registry Patient-Reported Data Validation Study

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Brief Title

VCRC Patient Contact Registry Patient-Reported Data Validation Study

Official Title

VCRC Validation of Patient-Reported Diagnostic Data

Brief Summary

      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.

Detailed Description

      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.

Study Type

Observational [Patient Registry]

Primary Outcome

Validation of the currently utilized VCRC Patient Contact Registry Questionnaire

Secondary Outcome

 Evaluate diagnostic accuracy of specific questions


Behcet's Disease

Study Arms / Comparison Groups

 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.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

May 2014

Completion Date

June 18, 2019

Primary Completion Date

December 1, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  At least 20 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 who have
             completed the online questionnaires.

        Exclusion Criteria:

          -  Inability to provide informed consent and complete survey

          -  Patients whose diagnosis of vasculitis was not confirmed by a physician

          -  Patients who did not complete the initial questionnaire in its entirety




N/A - N/A

Accepts Healthy Volunteers



Kathleen McKinnon, DO, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

University of South Florida


 Wayne State University

Study Sponsor

Kathleen McKinnon, DO, Study Chair, Henry Ford/Wayne State University

Verification Date

October 2019