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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011809
Receipt No. R000013808
Official scientific title of the study Retrospective multicenter clinical study of TAFRO syndrome.
Date of disclosure of the study information 2013/09/19
Last modified on 2018/03/24

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Basic information
Official scientific title of the study Retrospective multicenter clinical study of TAFRO syndrome.
Title of the study (Brief title) Retrospective multicenter clinical study of TAFRO syndrome.
Region
Japan

Condition
Condition TAFRO syndrome
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Nephrology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish a new disease concept of TAFRO syndrome, we will collect clinical data of patients with TAFRO syndrome.
Basic objectives2 Others
Basic objectives -Others clinical information
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Collection of clinical data and clinical course of patients with TAFRO syndrome.
Key secondary outcomes Collection of clinical data and clinical course of patients with Japanese type of multicentric Castlman's disease.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with TAFRO syndrome or Japanese type of multicentric Castlman's disease.
Key exclusion criteria malignancy
Target sample size 300

Research contact person
Name of lead principal investigator Yasufumi Masaki
Organization Kanazawa Medical University
Division name Hematology and Immunology
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-3511
Email yasum1macky1@gmail.com

Public contact
Name of contact person Yasufumi Masaki
Organization Kanazawa Medical University
Division name Hematology and Immunology
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-3511
Homepage URL https://www.facebook.com/CastlemanTAFRO?ref=stream
Email yasum1macky1@gmail.com

Sponsor
Institute Kanazawa Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization the Research Program of Intractable Disease provided by the Ministry of Health, Labor, and Welfare (MHLW) of Japan (H27-Nanchi,etc.(Nan)-General-008)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2013 Year 09 Month 19 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 09 Month 18 Day
Anticipated trial start date
2013 Year 09 Month 19 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 12 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Collection of clinical data of patients with TAFRO syndrome.

Management information
Registered date
2013 Year 09 Month 19 Day
Last modified on
2018 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013808


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