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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034188
Receipt No. R000038978
Scientific Title Biomarker analysis in Castleman's disease, TAFRO syndrome, and those related diseases
Date of disclosure of the study information 2018/09/19
Last modified on 2018/09/19

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Basic information
Public title Biomarker analysis in Castleman's disease, TAFRO syndrome, and those related diseases
Acronym Biomarker analysis in Castleman's disease
Scientific Title Biomarker analysis in Castleman's disease, TAFRO syndrome, and those related diseases
Scientific Title:Acronym Biomarker analysis in Castleman's disease
Region
Japan

Condition
Condition Castleman's disease, TAFRO syndrome, and those related diseases
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to identify biomarkers that contribute to the establishments of classification or diagnosis of Castleman's disease, the effective treatments, and the treatment guideline.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of biomarkers that contribute to the establishment of diagnosis of Castleman's disease, TAFRO syndrome, and those related diseases
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Castleman's disease or TAFRO syndrome who satisfy a diagnostic criteria proposed by "Health and Labour Sciences Research Grants for research on intractable diseases from Ministry of Health, Labour and Welfare of Japan" and patients who are difficult to distinguish from those diseases.
Key exclusion criteria Patients judged inappropriate as subjects of research.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Kawakami
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Rheumatology
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL 095-819-7200
Email atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Koga
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Rheumatology
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL 0958197200
Homepage URL
Email tkoga@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization No funding
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
2018 Year 09 Month 19 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
2018 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 09 Month 18 Day
Last modified on
2018 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038978

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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