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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002312
Receipt No. 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

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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
Email

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
Email yasum@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

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
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
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
URL(English) https://upload.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


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