UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007229 |
|---|---|
| Receipt number | 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 15:50:31 |
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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
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
Sponsor or person
Institute
Juntendo University,School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008516
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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