UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061530 |
|---|---|
| Receipt number | R000069953 |
| Scientific Title | Development of Personalized Medicine through Genomic Analysis of Acquired Inflammatory Diseases and Immunodeficiencies Using a National Registry |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/11 22:38:23 |
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Basic information
Public title
Development of Personalized Medicine through Genomic Analysis of Acquired Inflammatory Diseases and Immunodeficiencies Using a National Registry
Acronym
Development of Personalized Medicine through Genomic Analysis of Acquired Inflammatory Diseases and Immunodeficiencies Using a National Registry
Scientific Title
Development of Personalized Medicine through Genomic Analysis of Acquired Inflammatory Diseases and Immunodeficiencies Using a National Registry
Scientific Title:Acronym
Development of Personalized Medicine through Genomic Analysis of Acquired Inflammatory Diseases and Immunodeficiencies Using a National Registry
Region
| Japan |
Condition
Condition
Patients with suspected acquired autoinflammatory diseases and autoimmune diseases
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to clarify the role of acquired genetic alterations in unexplained or treatment-refractory inflammatory conditions and to establish a foundation for personalized medicine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival will be defined from the date of study enrollment. Patients alive at the end of follow-up or lost to follow-up after the last confirmed date of survival will be censored. The follow-up period will extend from enrollment to the end of the study.
Key secondary outcomes
Multi-omics and immunological functional analyses will be performed using specimens from enrolled patients.
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
1) Age 18 years or older
2) No restriction on sex
3) Patients with refractory inflammatory findings or those suspected of having an inflammatory disease by the treating physician
4) Written informed consent obtained for participation in this study
Key exclusion criteria
1) Patients in whom inflammation is clearly attributable to infection or malignancy
2) Patients whose inflammation can be explained by a known inflammatory or autoimmune disease fulfilling established international diagnostic criteria
3) Patients with an expected life expectancy of less than 1 year (e.g., terminal cancer)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Kirino |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
kirino@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Kirino |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
Homepage URL
kirino@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Yokohama City University Ethical Committee for Medical and Health Research Involving Human Subjects
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
045-370-7627
rinri@yokohama-cu.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 | 05 | Month | 11 | 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
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2037 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary Endpoint
Overall survival will be estimated using the Kaplan-Meier method, and survival curves will be generated. As this is an exploratory study, group comparisons and multivariable analyses will be conducted as exploratory analyses when the sample size is limited.
Secondary Endpoints
Clinical and molecular data will be summarized using descriptive statistics, and group comparisons will be performed using appropriate statistical tests (e.g., t-test, Mann-Whitney U test, chi-square test). Associations with disease activity and outcomes will be evaluated using logistic regression and Cox proportional hazards models. Omics data will be analyzed exploratorily using multiple testing correction (e.g., FDR), principal component analysis, clustering, and machine learning methods. Integrated analyses of clinical and molecular data will also be performed. All analyses will be conducted using statistical software such as R.
Patient Registration
An electronic data capture system will be used for patient registration and collection of clinical data. After obtaining written informed consent from the patient or a legally authorized representative, the investigator or sub-investigator will enter the required information and register the patient.
Management information
Registered date
| 2026 | Year | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069953
