The CARRA Registry
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Fibromyalgia, Lupus, Cardiology, Neurology, Ocular, Dermatology, Pain |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Musculoskeletal, Neurology, Ophthalmology, Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | October 2015 |
This CARRA Registry study will create a foundational database for rheumatic diseases of
childhood using a novel informatics infrastructure developed as part of the larger clinical
project. The creation of a CARRA-wide informatics infrastructure will enable efficient,
observational, disease-related data capture across all CARRA sites for pediatric rheumatic
diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more
data intensive registries for observational studies, comparative effectiveness research,
pharmaceutical clinical trials and translational research.
childhood using a novel informatics infrastructure developed as part of the larger clinical
project. The creation of a CARRA-wide informatics infrastructure will enable efficient,
observational, disease-related data capture across all CARRA sites for pediatric rheumatic
diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more
data intensive registries for observational studies, comparative effectiveness research,
pharmaceutical clinical trials and translational research.
This protocol represents one aim of a larger clinical project that will advance the
infrastructure of the Childhood Arthritis and Rheumatology Research Alliance (CARRA)
network, facilitate expanded clinical and translational pediatric research, and rapidly
transform the culture of pediatric rheumatology toward universal participation in research.
Through the creation of sophisticated informatics infrastructure, provision of comprehensive
site support and the engagement of families, patients, and communities, CARRA will provide
the opportunity for affected children at every CARRA site to participate in high quality
clinical and translational research.
The larger clinical project includes development of a CARRA-wide informatics platform with
capabilities for capture, storage, visualization, and secure HIPAA-compliant sharing of
validated disease metrics and relevant subject demographics, utilizing centralized
Electronic Data Capture (EDC) and phone interviews where appropriate, and ontology-based
data storage using a distributed database structure based on the NIH-supported i2b2
(Informatics Integrating Biology and the Bedside) framework. This will enable efficient,
observational, disease-related data capture across CARRA sites. The CARRA Registry described
in this protocol will form the foundational database and will involve the capture of data
including pediatric rheumatic diseases as described in Appendix A.
The CARRA Registry will support data collection from the use of consensus treatment plans
(CTPs), clinical trials, observational disease registries, comparative effectiveness
research, and other research on patients with pediatric rheumatic disease. The CARRA
Registry will form the basis for future CARRA studies and the Duke Clinical Research
Institute (DCRI) is serving as the CARRA Data Coordinating Center (DCC) for this protocol.
infrastructure of the Childhood Arthritis and Rheumatology Research Alliance (CARRA)
network, facilitate expanded clinical and translational pediatric research, and rapidly
transform the culture of pediatric rheumatology toward universal participation in research.
Through the creation of sophisticated informatics infrastructure, provision of comprehensive
site support and the engagement of families, patients, and communities, CARRA will provide
the opportunity for affected children at every CARRA site to participate in high quality
clinical and translational research.
The larger clinical project includes development of a CARRA-wide informatics platform with
capabilities for capture, storage, visualization, and secure HIPAA-compliant sharing of
validated disease metrics and relevant subject demographics, utilizing centralized
Electronic Data Capture (EDC) and phone interviews where appropriate, and ontology-based
data storage using a distributed database structure based on the NIH-supported i2b2
(Informatics Integrating Biology and the Bedside) framework. This will enable efficient,
observational, disease-related data capture across CARRA sites. The CARRA Registry described
in this protocol will form the foundational database and will involve the capture of data
including pediatric rheumatic diseases as described in Appendix A.
The CARRA Registry will support data collection from the use of consensus treatment plans
(CTPs), clinical trials, observational disease registries, comparative effectiveness
research, and other research on patients with pediatric rheumatic disease. The CARRA
Registry will form the basis for future CARRA studies and the Duke Clinical Research
Institute (DCRI) is serving as the CARRA Data Coordinating Center (DCC) for this protocol.
Inclusion Criteria:
- Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 18
years for all other rheumatic diseases
- Subject has been diagnosed with a defined pediatric rheumatic disease including:
Mixed Connective Tissue Disease (MCTD), Systemic Lupus Erythematosus (SLE), Primary
Sjögren's Syndrome (pSS), Systemic Sclerosis (SS), Juvenile Dermatomyositis (JDM),
Localized Scleroderma (LS), Juvenile Idiopathic Arthritis (JIA), Vasculitis, Sarcoid,
Auto-inflammatory Diseases, Idiopathic Uveitis (IU), and Juvenile Primary
Fibromyalgia Syndrome (JPFS).
- Subject (and/or parent/legal guardian when required) is able to provide written
informed consent and willing to comply with study procedures.
Exclusion Criteria:
- None
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