UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056734 |
|---|---|
| Receipt number | R000064831 |
| Scientific Title | Japan Cohort Study of Systemic Amyloidosis |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/01/15 01:26:12 |
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Basic information
Public title
Japan Cohort Study of Systemic Amyloidosis
Acronym
Japan Cohort Study of Systemic Amyloidosis
Scientific Title
Japan Cohort Study of Systemic Amyloidosis
Scientific Title:Acronym
RADDAR-J[8]
Region
| Japan |
Condition
Condition
Systemic amyloidosis
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
By accumulating clinical information on patients with systemic amyloidosis and continuing to examine evaluation items over the long term, we aim to elucidate the natural history and prognostic factors of systemic amyloidosis and contribute to the development and establishment of new treatments for systemic amyloidosis in the future.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accumulation of clinical information and genomic data on systemic amyloidosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with pathologically proven amyloid deposition in organs
2) Patients diagnosed with systemic amyloidosis by immunohistochemical testing of biopsy tissue using specific antibodies (AA, ALkappa, ALlambda, ATTR, Abeta2M)
3) Patients who have not undergone 1) or 2) above, but have been diagnosed with ATTRwt amyloidosis based on myocardial uptake in 99mTc bone scintigraphy
4) Patients who have given written consent to participate in the study
Key exclusion criteria
Patients who are judged by researchers to be inappropriate as study subjects
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Naiki |
Organization
University of Fukui
Division name
Department of Molecular Pathology
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8320
naiki@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Jin |
| Middle name | |
| Last name | Endo |
Organization
Keio University
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5843-6703
Homepage URL
attrcm.alljapanregistry@gmail.com
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
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
| 2025 | Year | 02 | Month | 01 | 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
| 2019 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2034 | Year | 03 | 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
| 2025 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064831
