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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040163
Receipt No. 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 2020/10/14

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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
Email m_taniguchi@shonankamakura.or.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
Email m08702012@gunma-u.ac.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization GlaxoSmithKline K.K
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
Email 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
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
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
2020 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045789

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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