UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060739 |
|---|---|
| Receipt number | R000069495 |
| Scientific Title | Cross-Disease Multi-Omics Analysis of Autoimmune and Autoinflammatory Disorders to Elucidate Pathogenic Mechanisms and Identify Stratification Biomarkers |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/02/24 17:55:03 |
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Basic information
Public title
Cross-Disease Multi-Omics Analysis of Autoimmune and Autoinflammatory Disorders to Elucidate Pathogenic Mechanisms and Identify Stratification Biomarkers
Acronym
Cross-Disease Multi-Omics Analysis of Autoimmune and Autoinflammatory Disorders to Elucidate Pathogenic Mechanisms and Identify Stratification Biomarkers
Scientific Title
Cross-Disease Multi-Omics Analysis of Autoimmune and Autoinflammatory Disorders to Elucidate Pathogenic Mechanisms and Identify Stratification Biomarkers
Scientific Title:Acronym
CROSS-Disease OMICS Analysis Study
Region
| Japan |
Condition
Condition
Cross-Disease Multi-Omics Analysis of Autoimmune and Autoinflammatory Disorders to Elucidate Pathogenic Mechanisms and Identify Stratification Biomarkers
Classification by specialty
| Medicine in general | Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
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
Basic objectives -Others
N/A
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Immunological abnormality clusters shared across multiple diseases (cellular populations and protein signatures) identified by flow cytometry and proteomic analyses
2. Disease-specific immunological features identified by multi-omics analyses, including cellular subsets, gene expression patterns, and protein signatures
3. Multi-omics biomarkers predictive of therapeutic responses to biologic agents and molecular targeted therapies (e.g., Olink proteomics and scRNA-seq)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 >=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 sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Koga |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
095-819-7262
tkoga@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Remi |
| Middle name | |
| Last name | Sumiyoshi |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
095-819-7262
Homepage URL
remis@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Research Ethics Committee
Address
1-7-1, Sakamoto, Nagasaki, Japan
Tel
095-819-7229
kenkyurinri@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 02 | Month | 24 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069495
