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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007229
Receipt No. R000008516
Scientific Title Clinical evaluation of EliA tests for MPO-ANCA and PR3-ANCA
Date of disclosure of the study information 2012/02/06
Last modified on 2012/11/30

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Basic information
Public title Clinical evaluation of EliA tests for MPO-ANCA and PR3-ANCA
Acronym Clinical evaluation of EliA tests for MPO-ANCA and PR3-ANCA
Scientific Title Clinical evaluation of EliA tests for MPO-ANCA and PR3-ANCA
Scientific Title:Acronym Clinical evaluation of EliA tests for MPO-ANCA and PR3-ANCA
Region
Japan

Condition
Condition Wegener's granulomatosis,Microscopic polyangiitis, allergic granulomatous angiitis,non antiNeutrophil cytoplasmic autoantibodies asocciated angiitis, connective tissue disease, Rheutomatoid arthritis,healthy control
Classification by specialty
Clinical immunology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate the clinical significance of EliA tests for MPO-ANCA and PR3-ANCA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) clinical sensitivity and specificity of Elia tests in disease controls and healthly controls.
2) Results of Elia tests in disease controls and healthly controls.

3)PR3-ANCA and MPO-ANCA EliA test in the follow-up of patient with Wegener's granulomatosis and Allergic granulomatous angiitis.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 obtain a blood sample
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Clinical infomation was retrieved for all of these patients and patients with a vasculitis were subgrouped according to the nomenclature of the Chapel Hill consensus conference, and for ANCA associated angiitis the criteria.
Key exclusion criteria not available
Target sample size 155

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinari Takasaki
Organization Juntendo University,School of Medicine
Division name Depertment of internal medicine and rheumatology
Zip code
Address 3-1-3 hongou bunnkyou-ku, Tokyo Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University,School of Medicine
Division name Depertment of internal medicine and rheumatology
Zip code
Address
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Juntendo University,School of Medicine
Institute
Department

Funding Source
Organization Juntendo University,School of Medicine
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
Address
Tel
Email

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
2012 Year 02 Month 06 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 Completed
Date of protocol fixation
2012 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 06 Day
Last modified on
2012 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008516

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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