VCRC Patient Contact Registry Patient-Reported Data Validation Study

Giant Cell Arteritis Clinical Trial

Official title: VCRC Validation of Patient-Reported Diagnostic Data

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arteritis
• Behcet Syndrome
• Behcet's Disease
• Churg-Strauss Syndrome
• Giant Cell Arteritis
• Granulomatosis with Polyangiitis
• Microscopic Polyangiitis
• Polyarteritis Nodosa
• Polymyalgia Rheumatica
• Takayasu Arteritis
• Takayasu's Arteritis
• Wegener Granulomatosis

• NCT number: NCT02190942
• Study type: Observational [Patient Registry]
• Source: University of South Florida
• Status: Completed
• Start date: May 2014
• Completion date: June 18, 2019