UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040163 |
|---|---|
| Receipt number | R000045789 |
| Scientific Title | Study for the pathogenesis of eosinophilic polyangiitis granulomatosis (EGPA) |
| Date of disclosure of the study information | 2020/04/20 |
| Last modified on | 2023/12/25 09:46:42 |
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Basic information
Public title
Study for the pathogenesis of eosinophilic polyangiitis granulomatosis (EGPA)
Acronym
Study for the pathogenesis of eosinophilic polyangiitis granulomatosis (EGPA)
Scientific Title
Study for the pathogenesis of eosinophilic polyangiitis granulomatosis (EGPA)
Scientific Title:Acronym
Study for the pathogenesis of eosinophilic polyangiitis granulomatosis (EGPA)
Region
| Japan |
Condition
Condition
Eosinophilic granulomatosis with polyangiitis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the mechanism of onset/acute exacerbation of Eosinophilic granulomatosis with polyangiitiseosinophilic polyangiitis granulomatosis (EGPA) using comprehensive analysis of microRNAs and cytokines, and assay of conventional biomarkers.
Basic objectives2
Others
Basic objectives -Others
To clarify the mechanism of onset/acute exacerbation of Eosinophilic granulomatosis with polyangiitiseosinophilic polyangiitis granulomatosis (EGPA) using comprehensive analysis of cytokines and assay of conventional biomarkers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in microRNA Expression between EGPA and Non EGPA Cases
Key secondary outcomes
1. Quantitative differences in cytokines/chemokines between EGPA and non EGPA cases.
2. Differences in microRNA Expression in EGPA Cases Before (= Active stage) and After several treatment (= Stable stage)
3. Quantitative Differences in Cytokines and Chemokines in EGPA Cases Before and After several treatment
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as follows in this hospital after April 2000
A. Cases diagnosed with EGPA
B. Cases of bronchial asthma that do not meet A
Key exclusion criteria
Individuals who are judged to be ineligible by the study representative or the treating physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Taniguchi |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara, Kanagawa, Japan.
TEL
042-742-8311
taniguchi.masami.wz@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Kamide |
Organization
Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
Homepage URL
m08702012@gunma-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKline K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
England
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sagamihara National Hospital ethical committee
Address
18-1 Sakuradai Minami-ku Sagamihara, Kanagawa, Japan.
Tel
042-742-8311
sugawara.rumi.rz@mail.hosp.go.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
| 2020 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
in submission
Publication of results
Unpublished
Result
URL related to results and publications
in submisson
Number of participants that the trial has enrolled
100
Results
In active EGPA, 33 proteins, mainly related to eosinophils, type 2 inflammation, and cell adhesion factors, were elevated compared to asthma. In contrast, 12 proteins were decreased with steroid treatment. Fifty-nine proteins, including functional proteins involved in cell proliferation, angiogenesis, and type 3 inflammation as well as eosinophilic inflammation, were altered by the additional administration of mepolizumab. MicroRNA coverage analysis showed 8 significantly different between EGPA and asthma.
Results date posted
| 2023 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fourteen patients with EGPA and 20 with bronchial asthma were enrolled, plus 11 patients with active EGPA treated with glucocorticoids and 13 patients treated with additional mepolizumab.
Participant flow
Not applicable because existing specimens were used.
Adverse events
Not applicable in this study
Outcome measures
Group differences in cytokines, chemokines, and microRNAs
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observarional study
Study duration:from 2020/4/20 to 2022/11/30
Subjects:All subjects that our hospital visited by EGPA or bronchial asthma, and met the selection criteria.
Management information
Registered date
| 2020 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045789
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
