ACTRN12621001564842招募中未知
The Australian Arthritis and Autoimmune Biobank Collaborative (A3BC): a national best-practice biobank-registry network for multi-centre prospective longitudinal collection, processing and storage of broad patient-reported and clinical/health data, and high-quality biospecimens from participants with inflammatory arthritis and autoimmune diseases
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 20,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •ALL DISEASES
- •Case Inclusion Criteria
- •Male, female or non-binary
- •Aged from 0-18 years for childhood musculoskeletal and autoimmune diseases.
- •Aged over 18 years for adult musculoskeletal and autoimmune diseases.
- •Allow their rheumatologist/ specialist to be notified of participation.
- •Formally diagnosed under validated classification systems related to the disease.
- •Able (in the Investigator’s opinion) and willing to comply with all study requirements.
- •Participant (or parent/guardian) is willing and able to give informed consent for participation.
- •Control Inclusion Criteria
- •Aged over 18 years
- •Controls are classified into three main subtypes:
- •a. At-Risk* first-degree and second-degree relatives of existing A3BC participants.
- •b. Healthy or at-risk* family and friends accompanying existing A3BC participants to their routine clinic visits.
- •c. Healthy or at-risk* general members of the community.
- •*Definitions of healthy or at-risk controls are detailed on a project-specific basis
- •---------------------------------
- •Inclusion Criteria
- •RA after symptom onset
- •Diagnosed with RA under the 2010 Rheumatoid Arthritis Classification Criteria published by the American College of Rheumatology (Group 1).
- •RA before symptom onset
- •Participants without RA who have at-risk RF and/or ACPA antibodies.
- •Inclusion Criteria
- •Children and adolescents aged 0-18 years.
- •Diagnosis of JIA (under ILAR Classification
- •Inclusion Criteria
- •At least 18 years of age
- •Diagnosis of PsA under the CASPAR Classification System
- •AS, nr-axSpA or PERIPHERAL SpA
- •Inclusion Criteria
- •At least 18 years of age
- •Diagnosis of AS under the modified New York Classification System or nr-axSpA / Peripheral SpA under the ASAS Classification Criteria
- •Inclusion Criteria
- •Diagnostic classification will be according to EULAR/ACR Criteria for each subtype of vasculitis:
- •- Small blood vessel vasculitis - Granulomatosis with polyangiitis (Wegener’s granulomatosis), Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), Goodpasture’s syndrome (Anti-glomerular basement membrane disease), Henoch-Schonlein purpura (IgA Vasculitis), Microscopic polyangiitis, Cogan’s disease, Cryoglobulinaemic vasculitis and Urticarial vasculitis
- •- Medium blood vessel vasculitis - Behcet’s disease, Central nervous system vasculitis, Kawasaki disease, Polyarteritis nodosa
- •- Large blood vessel vasculitis - Giant cell (temporal) arteritis, Takayasu arteritis, Polymyalgia rheumatica
- •In addition to EULAR/ACR Criteria, the rarer form of small blood vessel vasculitis, known as anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, will be identified by:
- •- Myeloperoxidase (MPO) or proteinase 3 (PR3) positive blood test (ELISA detection)
- •- ANCA-associated disease via vasculitis activity/ damage scoring (BVAS, DEI or VDI)
- •IDIOPATHIC INFLAMMATORY MYOPATHIES
- •Inclusion Criteria
- •Diagnosis under the 2017 EULAR/ACR IIMs Criteria Adult and Juvenile Idiopathic Inflammatory Myopathies
- •SJOGREN'S SYNDROME
- •Inclusion Criteria
- •Adults diagnosed under the 2016 EULAR/ACR Sjogren’s Syndrome Criteria or the American-European Consensus Sjögren’s Classification Criteria
- •Inclusion criteria
- •Adults diagnosed under the 2015 ACR/EULAR Gout Classification Criteria
排除标准
- •ALL DISEASES
- •Exclusion Criteria for Cases and Controls
- •Unable to speak English at a level capable of understanding the informed consent process, or lack of access to an interpreter to enable this level of understanding.
- •Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. For example, cognitive impairment that would interfere with completing a self-administered questionnaire.
- •Legacy/existing samples collected through participating sites will only be included in the A3BC network’s collections if they meet the current SOP parameters.
- •Exclusion Criteria Specific to Microbiome Collection – Cases and Controls
- •Given the inherent variability in microbiome populations and the myriad external factors which are thought to affect human microbial populations, the A3BC will carefully document and adjust for these in planned microbiome-related analyses. Microbiome research is a rapidly evolving field and therefore these criteria will be updated as levels of evidence evolve. Particular confounding variables to be minimised/documented in both faecal and saliva collections include antibiotic use, use of commercial probiotic/prebiotic products and infections (all in the last 3 months).
研究者
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