UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062878 |
|---|---|
| Receipt number | R000071989 |
| Scientific Title | Nationwide epidemiological survey of clinical practice and prognosis of large-vessel vasculitis in Japan |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/09/10 18:47:35 |
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Basic information
Public title
Nationwide epidemiological survey of Takayasu arteritis and giant cell arteritis in Japan
Acronym
Japan LVV Survey
Scientific Title
Nationwide epidemiological survey of clinical practice and prognosis of large-vessel vasculitis in Japan
Scientific Title:Acronym
Japan LVV Survey
Region
| Japan |
Condition
Condition
Large vessel vasculitis, Takayasu arteritis, giant cell arteritis
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Clinical immunology | Geriatrics | Vascular surgery |
| Ophthalmology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a nationwide epidemiological survey of patients with Takayasu arteritis (TAK) and giant cell arteritis (GCA) in Japan. The primary survey, conducted across medical institutions nationwide, aims to identify the number of patients treated for TAK and GCA and to estimate the total national patient population. The secondary survey collects data from pre-existing records (such as medical charts) of the identified patients, focusing on patient characteristics, diagnostic methods, clinical symptoms, laboratory findings, imaging findings, affected vessels, treatment regimens, treatment responsiveness, relapse, complications, and outcomes.
The primary endpoint is to evaluate the patient characteristics, diagnostic methods, treatment regimens, and clinical features of TAK and GCA patients in Japan. The secondary endpoints include exploratory analyses of: (1) comparisons of clinical presentations and treatment regimens between TAK and GCA; (2) clinical outcomes such as relapse, vascular complications, and mortality; and (3) longitudinal changes in patient characteristics, diagnostic methods, treatment strategies, and clinical outcomes compared with the previous nationwide epidemiological survey.
The purpose of this study is to clarify the current status of large vessel vasculitis management in Japan, evaluate changes in clinical practice since the previous nationwide epidemiological survey, and provide foundational data to support the future development of healthcare systems and clinical practice guidelines.
Basic objectives2
Others
Basic objectives -Others
Epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A survey on the number of patients with Takayasu arteritis and giant cell arteritis will be conducted targeting medical institutions nationwide extracted in accordance with the 'Manual for Nationwide Epidemiological Surveys to Estimate Patient Numbers and Clinical Epidemiology of Intractable Diseases (3rd Edition)' by the Ministry of Health, Labour and Welfare.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as large vessel vasculitis
Key exclusion criteria
N/A
Target sample size
9000
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Shirai |
Organization
Tohoku University Hospital
Division name
Department of Rheumatology
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
+81-22-717-7165
tsuyoshi.shirai.d8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University
Division name
Department of Clinical Immunology
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
+81-22-717-7165
Homepage URL
takahashi.miki.r3@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Tohoku University
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
+81-22-717-7165
tsuyoshi.shirai.d8@tohoku.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 | 11 | 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 | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nationwide epidemiological survey of clinical practice and prognosis of large-vessel vasculitis in Japan
Management information
Registered date
| 2026 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071989
