UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057747 |
|---|---|
| Receipt number | R000065973 |
| Scientific Title | Development of a Disease Registry and Specimen Repository for Adult-Onset Immunodeficiency Disorders and Implementation of a Prospective Observational Study |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/04/30 18:39:53 |
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Basic information
Public title
Development of a Disease Registry and Specimen Repository for Adult-Onset Immunodeficiency Disorders and Implementation of a Prospective Observational Study
Acronym
RAID Study
Scientific Title
Development of a Disease Registry and Specimen Repository for Adult-Onset Immunodeficiency Disorders and Implementation of a Prospective Observational Study
Scientific Title:Acronym
RAID Study
Region
| Japan |
Condition
Condition
Adult onset immunodeficiency disease; AOID
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the clinical background and actual treatment status of AOID in Japan, and to clarify the clinical course and prognosis of AOID by registering diagnosed cases as a disease registry and conducting a prospective cohort study.
Basic objectives2
Others
Basic objectives -Others
To collect cross-sectional information on the disease base in order to understand the actual status of medical treatment of adult-onset immunodeficiency diseases.
At the same time, the University will take the lead in establishing a disease registry and conducting a prospective cohort study to observe the course of the disease.
To establish a specimen repository to elucidate the pathomechanism of the disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Establish a registry and specimen repository of AOID cases in Japan
2) Creation of a database of information on cases at the time of diagnosis and their progress.
Key secondary outcomes
1) Changes in disease status after diagnosis
2) Changes in antibody titer after diagnosis
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 AOID cases enrolled in a previous study 30 cases
2 Adult patients who will have anti-IFN-gamma autoantibodies measured at the Department of Respiratory Medicine, Kumamoto University after the approval of this study in 2024 30 cases per year
Patients who fall under 1 or 2 must be able to visit the hospital once every 12 months in conjunction with their medical treatment.
3 Cases in which the patient's consent is obtained in writing.
Key exclusion criteria
(1) Cases under 18 years of age
(2) Other cases deemed inappropriate by the physician in charge
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Sakagami |
Organization
Kumamoto University Graduate School of Life Sciences
Division name
Respiratory Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto Prefecture
TEL
096-373-5012
stakuro@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Sakata |
Organization
Kumamoto University Graduate School of Life Sciences
Division name
Respiratory Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto Prefecture
TEL
096-373-5012
Homepage URL
ssakata@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Takuro Sakagami
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Niigata University Medical and Dental Hospital, Keio University School of Medicine, National Institute of Infectious Diseases, General South Tohoku Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Hospital Ethics Committee for Life Science and Medical Research, Department of Epidemiology and General
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto Prefecture
Tel
096-344-2111
ski-shien@jimu.kumamoto-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
| 2025 | Year | 05 | 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
| 2024 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is designed as a prospective observational study, not an intervention study.
Management information
Registered date
| 2025 | Year | 04 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065973
