UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023797 |
|---|---|
| Receipt number | R000027419 |
| Scientific Title | Study on susceptibility genes for SMON |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2016/08/28 14:26:38 |
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Basic information
Public title
Study on susceptibility genes for SMON
Acronym
Study on susceptibility genes for SMON
Scientific Title
Study on susceptibility genes for SMON
Scientific Title:Acronym
Study on susceptibility genes for SMON
Region
| Japan |
Condition
Condition
SMON(subacute myelo-optico-neuropathy)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will analyze a NQO1 polymorphism (C609T)which may affect toxicity of clioquinol and compare its allele frequencies between SMON and non-SMON Japanese populations.
Basic objectives2
Others
Basic objectives -Others
SMON was a drug disaster caused by clioquinol. NQO1 is an oxidoreductase which is expressed widely in human tissues and may importantfor reduction of clioquinol toxicity. Japanese has high frequency of "loss of function" allele of NQO1 (609T). SMON was prevalent in Japan even clioquinol was used in the world. We hypothesized that this "loss of function allele of C609T polymorphism is much more prevalent in SMON population than healthy Japanese population. If so, this may be explained why SMON was much more frequent in Japan than other countries.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Allele frequency of C609T of NQO1 gene
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
Diagnosed as having SMON
Key exclusion criteria
Non-SMON
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Fukao |
Organization
Graduate school of medicine, Gifu University
Division name
Department of Pediatrics
Zip code
Address
Yanagido 1-1, Gifu
TEL
058-230-6380
toshi-gif@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Fukao |
Organization
Graduate school of medicine, Gifu University
Division name
Department of Pediatrics
Zip code
Address
Yanagido 1-1, Gifu
TEL
058-230-6380
Homepage URL
toshi-gif@umin.net
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Health, Labor and Welfare of 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
Address
Tel
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
| 2017 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 08 | Month | 28 | Day |
Last modified on
| 2016 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027419
