Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060739) titled 'Cross-Disease Multi-Omics Analysis of Autoimmune and Autoinflammatory Disorders to Elucidate Pathogenic Mechanisms and Identify Stratification Biomarkers' on April 1.

Study Type: Observational

Primary Sponsor: Institute - Nagasaki University

Condition: Condition - Cross-Disease Multi-Omics Analysis of Autoimmune and Autoinflammatory Disorders to Elucidate Pathogenic Mechanisms and Identify Stratification Biomarkers Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - The objectives of this study are as follows: To characterize cross-disease immunopathology (shared immunological abnormalities) in autoimmune and autoinflammatory diseases. To identify disease-specific immunological features, including cellular populations and molecular signatures. To identify biomarkers predictive of therapeutic responses to biologic agents and molecular targeted therapies. To identify markers that enable stratification of disease subgroups. To characterize the spatial distribution of organ-specific immune responses in affected tissues. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old =18 years of age at the time of informed consent diagnosed with one of the following diseases: Systemic lupus erythematosus: Patients fulfilling the ACR classification criteria, SLICC classification criteria, or the 2019 ACR/EULAR classification criteria Rheumatoid arthritis: Patients fulfilling the 2010 ACR/EULAR classification criteria Idiopathic inflammatory myopathies: Patients fulfilling the Bohan and Peter criteria or the 2017 EULAR/ACR classification criteria Systemic sclerosis: Patients fulfilling the 2010 Japanese Ministry of Health, Labour and Welfare criteria or the 2013 ACR/EULAR classification criteria Castleman disease: Patients diagnosed based on histopathological findings TAFRO syndrome: Patients fulfilling the diagnostic criteria proposed by Masaki et al. Familial Mediterranean fever: Patients fulfilling international criteria or the Japan FMF diagnostic criteria Adult-onset Still's disease: Patients fulfilling the Yamaguchi criteria CAPS, TRAPS, PFAPA syndrome, and VEXAS syndrome: Patients diagnosed by a specialist Psoriasis and psoriatic arthritis: Patients diagnosed by a board-certified dermatologist or rheumatologist Discoid lupus erythematosus, parapsoriasis, atopic dermatitis, vitiligo, prurigo, acquired idiopathic generalized anhidrosis, pyoderma gangrenosum, urticaria, and cutaneous lymphoma: Patients diagnosed by a board-certified dermatologist Pemphigus, bullous pemphigoid, and mucous membrane pemphigoid: Patients diagnosed based on clinical findings, histopathology, and immunological examinations Individuals who have received a written explanation of the study and have provided written informed consent excluding those enrolled through an opt-out procedure. Key exclusion criteria - 1. Patients judged by the attending physician to lack the capacity to provide informed consent 2. Patients considered inappropriate for participation in this study by the principal investigator or sub-investigators Target Size - 500

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 31 Day Anticipated trial start date - 2026 Year 04 Month 01 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=R000069495

Disclaimer: Curated by HT Syndication.