UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062842 |
|---|---|
| Receipt number | R000071935 |
| Scientific Title | Nationwide Multicenter Study of Clinical Characteristics and Treatment of Kimura Disease in the Head and Neck |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/07 20:11:34 |
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Basic information
Public title
Nationwide Multicenter Study of Clinical Characteristics and Treatment of Kimura Disease in the Head and Neck
Acronym
Nationwide Multicenter Study of Clinical Characteristics and Treatment of Kimura Disease in the Head and Neck
Scientific Title
Nationwide Multicenter Study of Clinical Characteristics and Treatment of Kimura Disease in the Head and Neck
Scientific Title:Acronym
KIMURA study
Region
| Japan |
Condition
Condition
Kimura Disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Kimura disease is a relatively rare chronic inflammatory disorder that predominantly affects the head and neck region, and its clinical characteristics and optimal treatment strategies remain insufficiently understood. This nationwide multicenter study aims to collect and analyze clinical data from patients with Kimura disease involving the head and neck, including symptoms, lesion site, comorbidities, laboratory findings, treatment modalities, and clinical outcomes. The objectives are to characterize the patient demographics, clinical features, treatment patterns, and outcomes of Kimura disease in Japan and to provide evidence that may contribute to the establishment of appropriate clinical management strategies and improvement of treatment outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients receiving each treatment modality (surgery, pharmacotherapy, radiotherapy, etc.)
Response and recurrence rates according to treatment modality
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
| 5 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with Kimura disease. The diagnosis is primarily based on histopathological findings. Patients without histopathological confirmation may also be included if the attending physician at each participating institution diagnoses Kimura disease based on a comprehensive assessment of imaging findings, laboratory findings, and clinical course. Such patients will be classified as suspected cases in this study.
2.Patients with lesions involving the head and neck region.
3.Patients who received inpatient or outpatient care at the Department of Otolaryngology Head and Neck Surgery of a participating institution between January 1, 2010 and June 30, 2026.
4.Patients who have not opted out of participation in this study.
Key exclusion criteria
1.Patients who have opted out of participation in this study.
2.Patients who are deemed inappropriate for inclusion in the study by the principal investigator or other study investigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Morita |
Organization
University of Toyama
Division name
Department of Otolaryngology Head and Neck Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, Toyama
TEL
+81-76-434-7368
kentoko@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Ko |
Organization
University of Toyama
Division name
Department of Otolaryngology Head and Neck Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, Toyama-ken
TEL
+81-76-434-7368
Homepage URL
kentoko@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
3190 Gofuku, Toyama-shi, Toyama
Tel
076-415-8857
kenrinri@adm.u-toyama.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 | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2027 | Year | 01 | 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
This is a nationwide multicenter retrospective observational study of patients with Kimura disease involving the head and neck region. Clinical data, treatment modalities, and outcomes will be collected to investigate the clinical characteristics and treatment outcomes of Kimura disease in in otolaryngology head and neck surgery departments in Japan.
Management information
Registered date
| 2026 | Year | 09 | Month | 07 | Day |
Last modified on
| 2026 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071935
