UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052272 |
|---|---|
| Receipt number | R000059658 |
| Scientific Title | A Trial-ready Registry Study for Familial ALS: Japan Familial ALS Trial-ready (J-FAST) registry |
| Date of disclosure of the study information | 2023/11/30 |
| Last modified on | 2024/03/22 11:20:43 |
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Basic information
Public title
A Trial-ready Registry Study for Familial ALS: Japan Familial ALS Trial-ready (J-FAST) registry
Acronym
J-FAST registry
Scientific Title
A Trial-ready Registry Study for Familial ALS: Japan Familial ALS Trial-ready (J-FAST) registry
Scientific Title:Acronym
J-FAST registry
Region
| Japan |
Condition
Condition
Amyotrophic Lateral Sclerosis (ALS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In preparation for the arrival of the era of practical gene therapy, we will establish the Japan Familial ALS Trial-ready registry (J-FAST) for gene therapy for ALS.
Basic objectives2
Others
Basic objectives -Others
We will search for surrogate markers for the disease by validating our own candidate humoral and imaging biomarkers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ALSFRS-R
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
familial ALS
sporadic ALS younger than 40 y.o.
Key exclusion criteria
Cases that do not meet the diagnostic criteria for ALS
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Aoki |
Organization
Tohoku University Hospital
Division name
Neurology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7000
naoki.suzuki.e3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Tohoku University Hospital
Division name
Neurology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7000
Homepage URL
naoki.suzuki.e3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-7000
naoki.suzuki.e3@tohoku.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
| 2023 | Year | 11 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059658
| 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 |
