UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062932 |
|---|---|
| Receipt number | R000072055 |
| Scientific Title | Analysis of the molecular pathology of the vasculitis syndromes using clinical biopsies |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/15 14:55:10 |
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Basic information
Public title
Analysis of the molecular pathology of the vasculitis syndromes using clinical biopsies
Acronym
Analysis of the molecular pathology of the vasculitis syndromes
Scientific Title
Analysis of the molecular pathology of the vasculitis syndromes using clinical biopsies
Scientific Title:Acronym
Analysis of the molecular pathology of the vasculitis syndromes
Region
| Japan |
Condition
Condition
vasculitis designated intractable disease (Giant cell arteritis, Takayasu arteritis, polyarteritis nodosa etc.)
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate disease specific pathophysiological mechanisms in vasculitis syndromes by obtaining molecular data from blood and tissue samples collected for definitive diagnosis. Furthermore, the study seeks to identify factors correlating with disease activity and treatment response in each condition and to evaluate their utility in diagnostic and therapeutic strategies.
Basic objectives2
Others
Basic objectives -Others
Elucidation of the Pathophysiology of Vasculitis (designated as Intractable Disease)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of factors correlating with disease activity and treatment response in vasculitis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suspected of having refractory vasculitis who are undergoing diagnosis (e.g., via histopathology) or treatment, and who meet the following criteria:
(1) Patients who provide consent to participate in this study
(2) Patients aged 20 years or older
(3) Patients who are receiving outpatient care or are hospitalized at a participating medical institution
Key exclusion criteria
(1) Patients who do not provide consent for this study or who withdraw their consent
(2) Patients whom the attending physician deems unsuitable for participation in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobumasa |
| Middle name | |
| Last name | Watanabe |
Organization
Tokyo Metropolitan Institute of Medical Science (TMiMS)
Division name
Research Center for Genome & Medical Sciences
Zip code
156-8506
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL
03-5316-3100
watanabe-nb@igakuken.or.jp
Public contact
Name of contact person
| 1st name | Nobumasa |
| Middle name | |
| Last name | Watanabe |
Organization
Tokyo Metropolitan Institute of Medical Science (TMiMS)
Division name
Research Center for Genome & Medical Sciences
Zip code
156-8506
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL
03-5316-3100
Homepage URL
watanabe-nb@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science (TMiMS)
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan Institute of Medical Science (TMiMS)
Name of secondary funder(s)
Tokyo Metropolitan Hospital Organization
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute of Medical Science (TMiMS)
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
Tel
03-5316-3100
watanabe-nb@igakuken.or.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 | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 30 | 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
Study Design: Case-control study
Subject Recruitment: Patients who visited affiliated medical institutions on or after October 31, 2017, and met the inclusion criteria; and patients who visited affiliated medical institutions prior to that date, underwent tissue biopsy, and have preserved tissue samples.
Measurements/Analyses: Acquisition of molecular data (e.g., protein and gene expression analysis) using blood and tissue samples, and examination of the association with clinical information (e.g., clinical findings, treatment response).
Management information
Registered date
| 2026 | Year | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072055
