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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023797
Receipt No. 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

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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
Email 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
Email toshi-gif@umin.net

Sponsor
Institute Gifu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027419

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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