UMIN-CTR Clinical Trial

Basic information
Public title	A survey study based on international consensus building for the development and further improvement of medical guidelines for Castleman's disease, TAFRO syndrome and related diseases; RADDAR-J[77]
Acronym	Rare Disease Data Registry of Japan: Castleman's disease, TAFRO syndrome and related diseases; RADDAR-J[77]
Scientific Title	A survey study based on international consensus building for the development and further improvement of medical guidelines for Castleman's disease, TAFRO syndrome and related diseases: RADDAR-J[77]
Scientific Title:Acronym	RADDAR-J[77]
Region	Japan

Condition
Condition	Castleman's disease, TAFRO syndrome and related diseases
Classification by specialty	Hematology and clinical oncology Clinical immunology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	By accumulating clinical information on patients with Castleman's disease, TAFRO syndrome, and related diseases and examining endpoints on a sustained and long-term basis, we will elucidate the natural history and prognostic factors of the target diseases and contribute to the development and establishment of medical guidelines and treatment methods for the target diseases in the future.
Basic objectives2	Others
Basic objectives -Others	Accumulation of clinical information on patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accumulation of clinical information and genomic data on Castleman's disease, TAFRO syndrome, and 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	1) Patients with Castleman's disease, TAFRO syndrome who meet the diagnostic criteria described in the medical treatment guidelines developed by the Ministry of Health, Labour and Welfare's Policy Research Project on Intractable Diseases, "A survey study based on international consensus building for the development and further improvement of medical guidelines for Castleman's disease, TAFRO syndrome and related diseases" and patients who have difficulty in clinically differentiating between the two diseases. 2) Patients aged 16 years or older 3) Patients who have given written consent to participate in the study (excluding opt-out patients)
Key exclusion criteria	Patients judged to be inappropriate as a target by the judgment of researchers.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Kawakami
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL	095-819-7260
Email	atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Koga
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL	095-819-7262
Homepage URL
Email	tkoga@nagasaki-u.ac.jp

Sponsor
Institute	Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4642
Email	ethcom@kuhp.kyoto-u.ac.jp

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	2021 Year 12 Month 12 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	Open public recruiting
Date of protocol fixation	2021 Year 10 Month 12 Day
Date of IRB	2021 Year 10 Month 25 Day
Anticipated trial start date	2022 Year 01 Month 04 Day
Last follow-up date	2041 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Although the research period is permanent, ethical review approval and research permission will be obtained every five years.

Management information
Registered date	2021 Year 12 Month 12 Day
Last modified on	2022 Year 12 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052895