UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053771 |
|---|---|
| Receipt number | R000061364 |
| Scientific Title | Japanese Prospective Cohort Evaluating Features of Patients with UncontRolled Asthma Achieving Clinical REmission |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/19 15:37:55 |
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Basic information
Public title
Japanese Prospective Cohort Evaluating Features of Patients with UncontRolled Asthma Achieving Clinical REmission
Acronym
J-CIRCLE
Scientific Title
Japanese Prospective Cohort Evaluating Features of Patients with UncontRolled Asthma Achieving Clinical REmission
Scientific Title:Acronym
J-CIRCLE
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore clinical relevance of different proposed definitions of clinical remission, role of computed tomography, and predictive factors for long-term achievements of remission in patients with uncontrolled asthma receiving biologics
Basic objectives2
Others
Basic objectives -Others
Establishment of clinical evaluation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate whether clinical remission after 1-year treatement with biologics could reflect long-term clinical remission after 3-year treatment
Key secondary outcomes
To evaluate whether longitudinal changes in chest CT findings from baseline to 1-year after treatment could reflect long-term clinical remission.
To evaluate relapse rate during 3-year follow-up in patients who achieve 1-year clinical remission, and then discontinue biologics.
To evaluate whether clinical remission after 1-year biologics treatment could be associated with improvement of CT findings after 3-year treatment.
To evaluate whether baseline clinical factors and CT findings could predict 1-year and 3-year clinical remissions.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with uncontrolled asthma who will start a new biologic at age 20-90 years old
Key exclusion criteria
Patients who are considered inappropriate for enrollment.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | NAOYA |
| Middle name | |
| Last name | TANABE |
Organization
Kyoto University
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
+81-75-751-3830
ntana@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | NAOYA |
| Middle name | |
| Last name | TANABE |
Organization
Kyoto University
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
+81-75-751-3830
Homepage URL
ntana@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学病院、医学研究所北野病院、北海道大学、横浜市立大学、新潟大学医歯学総合病院、大阪公立大学、近畿大学、慶應義塾大学、滋賀医科大学、聖隷横浜病院、
大阪赤十字病院、友愛医療センター、大阪府済生会中津病院、大阪府済生会野江病院、神鋼記念病院、山口大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
| 2023 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study enrolls patients with uncontrolled asthma who will start biologics. After baseline examinations including demographics, comorbidities, blood test, FeNO, chest inspiratory/expiratory CT, paranasal sinus CT, the patients were followed up for 3 years. Exacerbation frequency, symptoms, and health-related quality of life will be evaluated after 1-month, 3-month, 6-month, 12-month, 24-month, and 36-month treatment. Chest CT scans were followed after 12-month and 36-month treatment.
Management information
Registered date
| 2024 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061364
