UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063548 |
|---|---|
| Receipt number | R000072460 |
| Scientific Title | Genetic Background Associated with Treatment Response and Clinical Remission in Severe Asthma |
| Date of disclosure of the study information | 2026/11/06 |
| Last modified on | 2026/11/06 17:21:05 |
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Basic information
Public title
Genetic Background Associated with Treatment Response and Clinical Remission in Severe Asthma
Acronym
J-CIRCLE Genomics
Scientific Title
Genetic Background Associated with Treatment Response and Clinical Remission in Severe Asthma
Scientific Title:Acronym
J-CIRCLE Genomics
Region
| Japan |
Condition
Condition
Severe Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore the genetic background associated with the achievement of clinical remission and treatment response to biologics in patients with severe asthma, through genetic analysis of participants in the J-CIRCLE cohort (Japanese Prospective Cohort Evaluating Features of Patients with Uncontrolled Asthma Achieving Clinical Remission). We also aim to identify novel endotypes of severe asthma by integrating genetic information with clinical data, serum biomarkers, and imaging findings.
Basic objectives2
Others
Basic objectives -Others
Exploration of genetic biomarkers predictive of treatment response and clinical remission
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genetic variants associated with the achievement of clinical remission with biologic therapy in patients with severe asthma
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with severe asthma who provided consent to participate in the Japanese Prospective Cohort Evaluating Features of Patients with Uncontrolled Asthma Achieving Clinical Remission (J-CIRCLE), a multicentre study of clinical remission in severe asthma conducted at the Department of Respiratory Medicine, Tokyo Women's Medical University, and its collaborating institutions
Key exclusion criteria
Patients judged by the principal investigator to be unsuitable for participation in the study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Kan-o |
Organization
Tokyo Women's Medical University
Division name
Department of Respiratory Medicine
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8112
kano.keiko@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kan-o |
Organization
Tokyo Women's Medical University
Division name
Department of Respiratory Medicine
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8112
Homepage URL
kano.keiko@twmu.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Tokyo Women's Medical University
Keiko Kan-o, MD, PhD
Institute
Department
Personal name
Keiko Kan-o
Funding Source
Organization
This study is supported by internal departmental funds and crowdfunding.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Ethics Committee
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8112
kano.keiko@twmu.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 | 06 | 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
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 | 04 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2027 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 11 | Month | 06 | Day |
Last modified on
| 2026 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072460
