UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlational study of gene polymorphism, prefrontal cortex activation and phenotype in children with autism spectrum disorder.
Title of the study (Brief title)	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	Kobayashi Masao
Organization	Hiroshima University Hospital
Division name	pediatrics
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5212
Email	masak@hiroshima-u.ac.jp

Public contact
Name of contact person	Kawamoto Akiko
Organization	Hiroshima University Graduate School of Biomedical & Health Sciences
Division name	Department of Pediatrics
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5212
Homepage URL
Email	d121709@hiroshima-u.ac.jp

Sponsor
Institute	Department of Pediatrics, Hiroshima University Graduate School of Biomedical & Health Sciences
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012354