Autism Spectrum Disorder Clinical Trial
Official title:
Deciphering the Autism Spectrum Disorder Beyond Genomics: AI Learning for Whole Exome Sequencing, Metabolomics and Phenotype
Verified date | September 2022 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators propose to study the molecular etiology of autism spectrum disorder(ASD) from a genomic, metabolomics and network biology perspective by combining data of gene expression, sequence variations and metabolism conditions of patients with ASD. As the complexity of ASD, the investigators consider both science-based and clinic-based measurements to ensure no missing of any relevant domain of the complex relations. In addition to the collection of biological factors, the investigators will also collect the comprehensive clinical, environmental, neurocognitive, MRI images to integrate the multiple factors into the matrix features. Finally the investigators will apply the machine learning to provide us the aspects of the underline pathway back into the other sample distribution published as the open dataset to verify and adjust the features in order to achieve satisfactory level of the reliability and stability of the algorithms. With Next Generation Sequencing (NGS) technology, the investigators will sequence the whole exome sequencing (WES) (MiSeq System) of approximately 120 ASD probands, 40 unaffecting siblings and 40 healthy controls of Taiwanese Han population to identify ASD-associated transcriptome profiles. The results will be using real-time PCR (qPCR) or conventional Sanger sequencing to verified. The investigators will use both liquid chromatography/time-of-flight mass spectrometry (LC-MS) and gas chromatography/quadrupole mass spectrometry (GC-MS) for a full assessment of a wide range of metabolites with over 820 metabolites. Hence, this 3-year proposal consists two main parts - the ASD transcriptome sequence analysis by NGS technology and the metabolomics study of ASD via LC-MS and GC-MS technology.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 20 Years |
Eligibility | Inclusion Criteria: - a clinical diagnosis of ASD defined by the DSM-5 made by board-certificated child psychiatrists at the first visit and following visits - ages range from 3 to 20 - at least one biological parent - parents that are both Taiwanese - subjects and their biological parents consent to participate in this study for complete phenotype assessments and blood withdraw for this study. Exclusion Criteria: - schizophrenia - schizoaffective disorder - organic psychosis. - Probands with fragile X, intellectual disability, epilepsy, ADHD, and autoimmune diseases will be noted. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan Univeristy Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ASD-associated transcriptome profiles | With Next Generation Sequencing (NGS) technology, the investigators will sequence the whole exome sequencing (WES) (MiSeq System) of approximately 120 ASD probands, 40 unaffecting siblings and 40 healthy controls of Taiwanese Han population to identify ASD-associated transcriptome profiles. | Baseline |
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