UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012528 |
|---|---|
| Receipt number | R000012354 |
| Scientific Title | Correlational study of gene polymorphism, prefrontal cortex activation and phenotype in children with autism spectrum disorder. |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2018/06/13 17:27:19 |
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Basic information
Public title
Correlational study of gene polymorphism, prefrontal cortex activation and phenotype in children with autism spectrum disorder.
Acronym
Correlational study of gene polymorphism, prefrontal cortex activation and phenotype in children with autism spectrum disorder.
Scientific Title
Correlational study of gene polymorphism, prefrontal cortex activation and phenotype in children with autism spectrum disorder.
Scientific Title:Acronym
Correlational study of gene polymorphism, prefrontal cortex activation and phenotype in children with autism spectrum disorder.
Region
| Japan |
Condition
Condition
autism spectrum disorder
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Investigate the relation of gene polymorphism, prefrontal cortex activation and cognitive function of autism spectrum disorder.
Basic objectives2
Others
Basic objectives -Others
neuroimaging
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the relation of genotype, prefrontal cortex activation, the result of cognitive task, and the score of questionnaire.
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
| 5 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Autism spectrum disorder
(a) Autism and Asperger syndrome diagnosed based on DSM-4.
(b) Subjects given informed consent.
Control
(a) Subjects given informed consent.
Key exclusion criteria
Autism spectrum disorder
(a) Subjects with hyperkinetic.
(b) Subjects who have had head injury with disturbance of consciousness for more than 5 minutes.
(c) Subjects who are judged to be not appropriate by the investigator.
Control
(a) Subjects who have been pointed out to have abnormality in development by the health examination for young children.
(b) Subjects who have difficulty in social life.
(c) Subjects who have had head injury with disturbance of consciousness for more than 5 minutes.
(d) Subjects who are judged to be not appropriate by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kobayashi Masao |
Organization
Hiroshima University Hospital
Division name
pediatrics
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5212
masak@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kawamoto Akiko |
Organization
Hiroshima University Graduate School of Biomedical & Health Sciences
Division name
Department of Pediatrics
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5212
Homepage URL
d121709@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Hiroshima University Graduate School of Biomedical & Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Hiroshima University Graduate School of Biomedical & Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 10 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
We investigate if gene polymorphism associate with phenotype through brain activation.
Management information
Registered date
| 2013 | Year | 12 | Month | 09 | Day |
Last modified on
| 2018 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012354
