UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034188 |
|---|---|
| Receipt number | 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 | 2021/03/23 18:31:56 |
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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 Ministry of Health, Labour and Welfare (MHLW) Policy Research 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 (Team Kawakami) " and patients who are difficult to distinguish from those diseases.
Key exclusion criteria
Patients judged inappropriate as subjects of research.
Target sample size
50
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
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL
0958197262
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
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL
0958197262
Homepage URL
tkoga@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants for Intractable Diseases Policy Research Project
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
Clinical Research Center, Nagasaki University hospital
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
Tel
0958197262
remis@nagasaki-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
| 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
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
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038978
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
