UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030729 |
|---|---|
| Receipt number | R000035087 |
| Scientific Title | Association between genotype and clinical course of amyotrophic lateral sclerosis |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2020/07/12 18:44:22 |
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Basic information
Public title
Association between genotype and clinical course of amyotrophic lateral sclerosis
Acronym
Association between genotype and clinical course of amyotrophic lateral sclerosis
Scientific Title
Association between genotype and clinical course of amyotrophic lateral sclerosis
Scientific Title:Acronym
Association between genotype and clinical course of amyotrophic lateral sclerosis
Region
| Japan |
Condition
Condition
amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effect of gender mutation and clinical information in patients with familial amyotrophic lateral sclerosis and the effects of edaravone and riluzole.
Basic objectives2
Others
Basic objectives -Others
natural history
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the relationship between gene mutation and information on medical record. Information on the medical record includes information on age, sex, height, weight, past history, age of onset, onset form, diagnosis findings and aging, ALSFRS-R (ALS function evaluation scale), riluzole and edaravone.
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
Patients who are diagnosed as ALS, genetic analysis is performed with the review of the ethical committee on the human genome and genetic analysis research and approval of the hospital director, and patients with mutations in known genes
Key exclusion criteria
Cases for which patients or the legal representatives did not agree are excluded. Patients who did not have gene mutation as a result of genetic analysis examination are excluded.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Kanzaki |
Organization
Toranomon Hospital Kajigaya
Division name
Department of Neurology
Zip code
213-0015
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki-shi, Kanagawa
TEL
044-877-5111
mami.kanzaki@gmail.com
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Kanzaki |
Organization
Toranomon Hospital Kajigaya
Division name
Department of Neurology
Zip code
213-0015
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki-shi, Kanagawa
TEL
044-877-5111
Homepage URL
mami.kanzaki@gmail.com
Sponsor or person
Institute
Toranomon Hospital Kajigaya
Institute
Department
Personal name
Funding Source
Organization
Okinaka memorial institute for medical research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
The University of Tokyo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital Kajigaya
Address
1-3-1 Kajigaya, Takatsu-ku, Kawasaki-shi, Kanagawa
Tel
044-877-5111
kakumoto-tky@umin.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
虎の門病院分院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 25 | 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
0
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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
inhalted
Management information
Registered date
| 2018 | Year | 01 | Month | 09 | Day |
Last modified on
| 2020 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035087
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
