- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190942
VCRC Patient Contact Registry Patient-Reported Data Validation Study
October 15, 2019 updated by: University of South Florida
VCRC Validation of Patient-Reported Diagnostic Data
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.
Study Overview
Status
Completed
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
Enrollment (Actual)
198
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- University of South Florida Data Management Coordinating Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
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.
The sensitivity and specificity for various combinations of the diagnostic questions to predict vasculitis and to confirm type of vasculitis will be calculated using physician diagnosis / chart review as the gold standard.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Vasculitis Contact Registry Patients
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of the currently utilized VCRC Patient Contact Registry Questionnaire
Time Frame: Up to 24 months from the date of the last patient assessment
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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.
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Up to 24 months from the date of the last patient assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate diagnostic accuracy of specific questions
Time Frame: Up to 24 months form the last patient assessment received
|
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.
|
Up to 24 months form the last patient assessment received
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Kathleen McKinnon, DO, Henry Ford/Wayne State University
- Study Chair: Ximena D. Ruiz, MD, University of Pittsburgh
- Study Chair: Jennifer L. Harris, MSPH, CCRP, University of South Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2014
Primary Completion (ACTUAL)
December 1, 2017
Study Completion (ACTUAL)
June 18, 2019
Study Registration Dates
First Submitted
May 30, 2014
First Submitted That Met QC Criteria
July 11, 2014
First Posted (ESTIMATE)
July 15, 2014
Study Record Updates
Last Update Posted (ACTUAL)
October 16, 2019
Last Update Submitted That Met QC Criteria
October 15, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Lung Diseases
- Eye Diseases
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Uveitis, Anterior
- Panuveitis
- Uveitis
- Uveal Diseases
- Vasculitis
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Lung Diseases, Interstitial
- Cerebral Small Vessel Diseases
- Vasculitis, Central Nervous System
- Systemic Vasculitis
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Granuloma
- Aortic Diseases
- Behcet Syndrome
- Polymyalgia Rheumatica
- Giant Cell Arteritis
- Arteritis
- Granulomatosis with Polyangiitis
- Microscopic Polyangiitis
- Churg-Strauss Syndrome
- Polyarteritis Nodosa
- Takayasu Arteritis
- Aortic Arch Syndromes
Other Study ID Numbers
- 5535
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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