UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002312 |
|---|---|
| Receipt number | R000002823 |
| Scientific Title | Multicenter diagnostic study for IgG4+MOLPS, Castleman's disease, and other polyclonal hypergammopathies |
| Date of disclosure of the study information | 2009/08/10 |
| Last modified on | 2012/02/09 16:11:55 |
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Basic information
Public title
Multicenter diagnostic study for IgG4+MOLPS, Castleman's disease, and other polyclonal hypergammopathies
Acronym
IgG4 prospective diagnostic study
Scientific Title
Multicenter diagnostic study for IgG4+MOLPS, Castleman's disease, and other polyclonal hypergammopathies
Scientific Title:Acronym
IgG4 prospective diagnostic study
Region
| Japan |
Condition
Condition
IgG4+MOLPS, Castleman's disease, other polyclonal hypergammopathies, male Sjogen's syndrome
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Ophthalmology |
| Oto-rhino-laryngology | Urology | Oral surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
For making the diagnostic criteria of IgG4+MOLPS
Basic objectives2
Others
Basic objectives -Others
For searching novel serological, genetical or histological markers.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Definition of diagnostic criteria of IgG4+MOLPS; assessment of glucocorticoid response.
Key secondary outcomes
Collection of clinical data, tissue, serum and lymphocytes. Proteomics and genomics analysis.
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
1, IgG4+MOLPS
2, Other polyclonal hypergammopathy;
Castleman's disease, Crow-Fukase syndrome, male Sjogren's syndrome, etc.
3, age morethan 19 yrs
4, written informed consent
Key exclusion criteria
Distinct monoclonal gammopathy such as Myeloma, Macroglobulinemia.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Hematology & Immunology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa
TEL
076-286-3511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Hematology & Immunology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa
TEL
076-286-3511
Homepage URL
http://www.kanazawa-med.ac.jp/~hematol/topics4.html
yasum@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
IgG4+MOLPS research group, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 08 | Month | 10 | 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
| 2009 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Prospective study, Collecting samples of IgG4+MOLPS, Casteman's disease, and similar cases.
Management information
Registered date
| 2009 | Year | 08 | Month | 09 | Day |
Last modified on
| 2012 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002823
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
