UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046356 |
|---|---|
| Receipt number | R000052895 |
| 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] |
| Date of disclosure of the study information | 2021/12/12 |
| Last modified on | 2022/12/13 09:47:19 |
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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
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
tkoga@nagasaki-u.ac.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052895
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
