UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060273 |
|---|---|
| Receipt number | R000068945 |
| Scientific Title | Investigation of autism spectrum disorder subtypes using whole-cortex level omics analysis |
| Date of disclosure of the study information | 2026/01/06 |
| Last modified on | 2026/01/06 16:48:35 |
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Basic information
Public title
Molecular subtyping of autism spectrum disorder using whole-cortex omics analysis
Acronym
ASD whole-cortex omics study
Scientific Title
Investigation of autism spectrum disorder subtypes using whole-cortex level omics analysis
Scientific Title:Acronym
ASD whole-cortex omics
Region
| Japan |
Condition
Condition
Autism spectrum disorder (ASD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To analyze anonymized existing multi-omics data (bulk and single-cell transcriptomics, ATAC-seq, histone acetylation, DNA methylation, miRNA, etc.) from 11 cortical regions in ASD and control subjects stored in the PsychENCODE/NRGR database, and to characterize molecular subtypes of ASD across cortical regions and examine their associations with clinical and behavioral phenotypes.
Basic objectives2
Others
Basic objectives -Others
As an observational secondary analysis of existing de-identified data, to explore differential molecular signatures (gene expression and epigenomic measures) among ASD subtypes and their relationships with clinical phenotypes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of molecular subtypes of ASD based on cortical multi-omics profiles (clustering-derived subtype classification).
Key secondary outcomes
(1) Differential molecular features among subtypes (gene expression, ATAC-seq, histone acetylation, DNA methylation, miRNA, etc.)
(2) Associations between subtypes and clinical/behavioral measures (e.g., ADI-R, ADOS, IQ).
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
| 3 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Anonymized existing data of individuals diagnosed with autism spectrum disorder (ASD) and healthy controls stored in the PsychENCODE Knowledge Portal managed by the NIMH Repository and Genomics Resource (NRGR), with available diagnostic assessments such as ADI-R and ADOS.
Key exclusion criteria
Cases lacking sufficient diagnostic information or having medical or genetic conditions deemed to substantially affect the validity of the analyses.
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | Noritaka |
| Middle name | |
| Last name | Ichinohe |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Ultrastructural Research, National Institute of Neuroscience
Zip code
187-8502
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo, Japan
TEL
0423461719
nichinohe72@gmail.com
Public contact
Name of contact person
| 1st name | Noritaka |
| Middle name | |
| Last name | Ichinohe |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Ultrastructural Research, National Institute of Neuroscience
Zip code
187-8502
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8502, Japan
TEL
0423461719
Homepage URL
nichinohe72@gmail.com
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Noritaka Ichinohe
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8502, Japan
Tel
0423461719
nichinohe72@gmail.com
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
| 2026 | Year | 01 | Month | 06 | 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
165
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
| 2024 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational analysis using existing anonymized database data and does not involve new participant enrollment or follow-up.
Management information
Registered date
| 2026 | Year | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068945
