Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062779) titled 'Elucidation of Disease Mechanisms and Establishment of a Stratification Platform for Autoimmune and Autoinflammatory Diseases through Cross-Disease Integration of Genomic and Spatial Multi-Omics Data' on Oct. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Nagasaki University
Condition:
Condition - Systemic lupus erythematosus, rheumatoid arthritis, idiopathic inflammatory myopathies, systemic sclerosis, Sjogrens syndrome, IgG4 related disease, ANCA associated vasculitis, other vasculitis syndromes, Castleman disease, TAFRO syndrome, familial Mediterranean fever, adult onset Stills disease, cryopyrin associated periodic syndrome, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Lymphadenitis Syndrome, VEXAS syndrome, Behcets disease, discoid lupus erythematosus, psoriasis and psoriatic arthritis, psoriasiform dermatosis, atopic dermatitis, pemphigus and pemphigoid like conditions and mucosal pemphigoid like conditions, vitiligo, prurigo, idiopathic acquired generalized anhidrosis, pyoderma gangrenosum, urticaria, cutaneous lymphoma, palmoplantar pustulosis, cutaneous granulomatosis, such as annular granuloma
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - Elucidation of cross-disease immunopathologies in autoimmune and autoinflammatory diseases
Identification of disease-specific immunological characteristics
Screening for biomarkers to predict treatment response to biologics, molecularly targeted drugs, and other therapies
Identification of markers to aid in the stratification of disease subgroups
Elucidation of the spatial distribution of gene expression, protein expression, and chromatin states in affected organs, as well as intercellular interactions
Characterization of immunometabolic abnormalities in autoimmune and autoinflammatory diseases and elucidation of their relationship with immunological abnormalities and inflammatory pathophysiology
Elucidation of the relationship between serum antibody titers against periodontal disease-associated bacteria and disease activity and immunological markers in patients with autoimmune and autoinflammatory diseases
Exploring the genetic background associated with clinical phenotypes-such as treatment response, adverse events, disease activity, disease progression, and prognosis-in various diseases using methods such as GWAS, and elucidating their associations with gene expression, protein expression, and chromatin status
Among existing study participants, those with autoinflammatory diseases, Castleman disease, SLE, SjD, IIM, SSc, psoriasis, and autoimmune bullous diseases to prospectively evaluate the co-occurrence of ME/CFS and explore clinical, immunological, and genetic characteristics, including comparisons with cases of the same underlying disease without ME/CFS
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Participants must meet all of the following criteria
Adult patients over 18 years old at the time of informed consent diagnosed with one of the following diseases;
Systemic lupus erythematosus, Rheumatoid arthritis, Idiopathic inflammatory myopathies, Hereditary muscle diseases, muscular dystrophy, congenital myopathies, metabolic muscle diseases, etc., Systemic sclerosis, Sjogrens disease, IgG4-related disease, ANCA-associated vasculitis, microscopic polyangiitis, polyangiitis nodosa, eosinophilic polyangiitis, Other vasculitis syndromes, giant cell arteritis, Takayasu arteritis, polyarteritis nodosa, IgA vasculitis, cryoglobulinemic vasculitis, antiglomerular basement membrane disease, Nephritic syndromes, tubulointerstitial nephritis, and metabolic kidney diseases, Castleman disease, TAFRO syndrome, Familial Mediterranean fever, Adult-onset Stills disease, CAPS, TRAPS, PFAPA syndrome, VEXAS syndrome, Psoriasis and psoriatic arthritis, Discoid lupus erythematosus, psoriasiform dermatitis, atopic dermatitis, vitiligo, prurigo, idiopathic acquired generalized anhidrosis, pyoderma gangrenosum, urticaria, angioedema, alopecia areata, hypertrophic dermoperiosteitis, elastic fiber pseudoxanthoma, serpiginous perforating elastic fiberosis, cutaneous lymphoma, Pemphigus, pemphigoid, and mucosal pemphigoid, Palmar-plantar pustulosis, cutaneous granulomatosis.
Disease Control Group
Healthy Controls
Individuals who have received a written explanation of the purpose and content of this study and have provided written informed consent to participate in the study. For study participants for whom only existing samples and information are used, this includes individuals who have followed the appropriate procedures, such as opting out, as specified in the research protocol.
Key exclusion criteria - Healthy control subjects who meet any of the following criteria: have a history of or current comorbidity of a disease listed in Inclusion Criterion 1; are currently taking immunosuppressive medications; have an active infectious disease; or are pregnant
Disease control subjects who do not meet the selection criteria for cases requiring differential diagnosis from the study disease
Any other subjects whom the principal investigator or a co-investigator deems unsuitable for participation in this study
Target Size - 550
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 01 Day
Anticipated trial start date - 2026 Year 10 Month 15 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071874
Disclaimer: Curated by HT Syndication.
