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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043634
Receipt No. R000049825
Scientific Title Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/16

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Basic information
Public title Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex
Acronym Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex
Scientific Title Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex
Scientific Title:Acronym Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex
Region
Japan

Condition
Condition ANCA-associated vasculitis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the role of ApoA1-VAP2 complex in patients with ANCA-associated vasculitis
Basic objectives2 Others
Basic objectives -Others To establish the measuring system of ApoA1-VAP2 complex by ELISA
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes serum ApoA1-VAP2 complex levels in active/inactive ANCA-associated vasculitis and healthy control
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ANCA-associated vasculitis patients who fulfilled the definition of 2012 Chapel Hill Consensus Conference
Key exclusion criteria 1. Less than 20 years old
2. Eosinophilic granulomatosis with polyangiitis
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shunsuke
Middle name
Last name Furuta
Organization Chiba University Hospital
Division name Allergy and Clinical Immunology
Zip code 260-8670
Address 1-8-1 Inohana, Chuou-ku, Chiba
TEL 0432227171
Email shfuruta@gmail.com

Public contact
Name of contact person
1st name Shunsuke
Middle name
Last name Furuta
Organization Chiba University Hospital
Division name Allergy and Clinical Immunology
Zip code 260-8670
Address 1-8-1 Inohana, Chuou-ku, Chiba
TEL 0432227171
Homepage URL
Email shfuruta@gmail.com

Sponsor
Institute Chiba University Hospital
Institute
Department

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 institutional review board of Chiba University
Address 1-8-1 Inohana, Chuou-ku, Chiba
Tel 0432227171
Email inohana-rinri@chiba-u.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
2021 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 Enrolling by invitation
Date of protocol fixation
2021 Year 01 Month 21 Day
Date of IRB
2021 Year 02 Month 22 Day
Anticipated trial start date
2021 Year 02 Month 22 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a study investigating the disease mechanism without any intervention. Serum ApoA1-VAP2 complex levels will be measured using blood samples from ANCA-associated vasculitis patients. ApoA1-VAP2 complex is known as an aggravating factor of the disease in the mice model.
Our IRB recommended us to register this study, though this study is not a clinical trial.

Management information
Registered date
2021 Year 03 Month 16 Day
Last modified on
2021 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049825

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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