UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022934 |
|---|---|
| Receipt number | R000026434 |
| Scientific Title | Usefulness of new antibody detection in patients with IgG4 related disease ~ prospective study |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2016/06/28 23:21:27 |
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Basic information
Public title
Usefulness of new antibody detection in patients with IgG4 related disease ~ prospective study
Acronym
New antibody analysis in patients with IgG4 related disease
Scientific Title
Usefulness of new antibody detection in patients with IgG4 related disease ~ prospective study
Scientific Title:Acronym
New antibody analysis in patients with IgG4 related disease
Region
| Japan |
Condition
Condition
IgG4 related disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Cardiology |
| Pneumology | Endocrinology and Metabolism | Nephrology |
| Clinical immunology | Ophthalmology | Dermatology |
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyse usefulness of new antibody detection in patients with IgG4 related disease for diagnosis and diseas activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analysisng sensitivity and specificity to diagnose IgG4 related disease
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
the patients fullfilig japanese criteria of IgG4 related disease, autoimmune pancreatitis, IgG4 related sclerosing cholangitis, IgG4 related kidney disease, and IgG4 related lacrimial/orbital disease
Key exclusion criteria
under 20 year old or patients who did not agree written consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kodama Yuzo |
Organization
Kyoto university
Division name
gastroenterology and hepatology
Zip code
Address
kyoto prefacture kyoto city shogoin kawahara town 54
TEL
075-751-4319
kodamayu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiokawa Masahiro |
Organization
Kyoto university
Division name
gastroenterology and hepatology
Zip code
Address
kyoto prefacture kyoto city shogoin kawahara town 54
TEL
075-751-4319
Homepage URL
machan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
gastroenterology and hepatology
Institute
Department
Personal name
Funding Source
Organization
Kyoto university
gastroenterology and hepatology
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
| 2016 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
to analyse usefullness of new antibody detection at diagnosis, during follow up, and at relapse of IgG4 related disease
Management information
Registered date
| 2016 | Year | 06 | Month | 28 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026434
