Autism Spectrum DisorderNCT04875481
Precise Objective Automated Assessment System of Autism Spectrum Disorder From an Existing Big Cohort
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The project's significance includes a big cohort of Autism spectrum disorder (ASD), originality/novelty (new approaches and technologies including next-generation sequencing, multi-echo functional MRI, metabolomics, microbiomics, and machine learning), and the integration of multi-dimentional measures. Read more about this study
- Who is it for?
- Ages 4 to 25 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Psychiatric diagnosis and ASD diagnosis
- How many people
- 214 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2018to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The cohort was established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007. No less than 450 ASD and 100 healthy typical developing control (TDC) would be selected from the original cohort.
Who may be able to join
- Clinical diagnosis of ASD defined by the DSM-IV confirmed by ADI-R or ADOS
- At least one biological parent
- Parents are both Han Chinese in Taiwan
Who cannot join
- Schizophrenia
- Schizoaffective disorder
- Organic psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Precise Objective Automated Assessment System of Autism Spectrum Disorder by Integrating the Imaging, Next-Generation Sequencing, Microbiomics, and Metabolomics From an Existing Big Cohort
The project's significance includes a big cohort of Autism spectrum disorder (ASD), originality/novelty (new approaches and technologies including next-generation sequencing, multi-echo functional MRI, metabolomics, microbiomics, and machine learning), and the integration of multi-dimentional measures. With the accomplishment of this project, we will establish the most comprehensive ASD bio-bank in Asia, develop ASD NGS panel, identify several ASD biomarkers, publish at least 15 SCI papers in total, and in the end, have patents registration and technology transfer of our precise objective, automated assessment system for ASD. Our findings will further advance our understanding of ASD, ultimately contribute to the early detection, diagnosis, and treatment of ASD, and be the first step of precise medicine for ASD.
Read the detailed description
Autism spectrum disorder (ASD) is a common highly heritable neurodevelopmental disorder with high genetic and clinical heterogeneity. Due to its high prevalence, long-term impairment, unclear etiologies, and a lack of effective detection, prevention and biological treatment for this disorder, this catastrophic disorder has been prioritized for molecular genetic and brain research. The main PI Gau has established a cohort of more than 900 ASD probands and their families with clinical, neuropsychological, image, and genetic data. With the advance in digit health, this integrated project aims to develop and potentially commercialize an objective, automated assessment system for early diagnosis of ASD based on the clinical, behavioral, neuropsychological, neuroimaging, genetic (whole exome sequencing, WES), metabolomics, and microbiomics data of probands with ASD and typically developing controls(TDC) without ASD
This 3-year, 5 subprojects (SP) project is based on an existing big cohort of > 900 ASD probands and their families with high-quality genetic data, clinical diagnoses, symptoms, psychopathology, social functions, neuropsychological functions (n= 600 for CPT, 300 for CANTAB), and structural and functional images (n=196), data. Due to a limited budget, SP1 will only select 360 ASD (ages 4-25 years old) and 90 TDC for this integrated project. SP1 will check the quality and presence of the data followed by recollecting DNAs of 100 ASD, MRI data of 205 ASD (360-196=164, 164/0.8(successful rate)=205), and CANTAB of 60 ASD to have a complete dataset of clinical/phenotype/neurocognition/image measures. SP1 will prepare DNAs for SP2's WES analyses; and will collect serum and stool of 360 ASD and 90 TDC and provide these samples to SP3 and SP4 for metabolomics and microbiomics analyses, respectively. All the data collected and results generated from SP1-4 will be saved and managed in the ASD bank (SP1, main PI) and analyzed by SP5 using AI machine learning to develop the precise objective automatic assessment platform for ASD. The topics of the five subprojects:
Subproject 1. Establishing the standard procedure for data collection and clinical-biological bank of autism spectrum disorder including clinical, behavioral, cognitive, neuroimaging, genetic, and biological data Subproject 2. Deciphering genetic cause in autistic spectrum disorder using whole exome sequencing Subproject 3. Metabolomics investigation of Autism Spectrum Disorder Subproject 4. Intestinal microbiota and disease outcome in children with autism spectrum disorder Subproject 5. A computerized assessment system from genome, gut-brain, and metabolic mechanisms
- Conditions
- Autism Spectrum Disorder
- Being tested
- Psychiatric diagnosis, ASD diagnosis
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric diagnosisOther
Kiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5
ASD diagnosisOther
Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
| Study group | Role | What they receive |
|---|---|---|
| ASD group | 450 ASD from cohort established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007. Receives: Other: Psychiatric diagnosis; Other: ASD diagnosis | |
| TD group | 100 healthy typical developing control (TDC) from cohort established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007. Receives: Other: Psychiatric diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism diagnostic interview (ADI-R)
Including reciprocal social interaction, communication, and repetitive behaviors and stereotyped patterns, for children with a mental age from about 18 months into adulthood
Measured: 4 hours
Neuropsychological functions: Continuous Performance Test(CPT)
The 4 dimensions of CCPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance
Measured: 15 minutes
Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)
The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Aug 2018
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875481
- Sponsor's protocol ID
- 201801038RINB
- Status last verified
- Sep 2022
- First submitted
- 29 Apr 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Objective Automated Assessment System of Autism Spectrum Disorder by Integrating the Imaging, Next-Generation Sequencing, Microbiomics, and Metabolomics From an Existing Big Cohort
- ClinicalTrials.gov ID
- NCT04875481
- Acronym / sponsor ID
- 201801038RINB
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project's significance includes a big cohort of Autism spectrum disorder (ASD), originality/novelty (new approaches and technologies including next-generation sequencing, multi-echo functional MRI, metabolomics, microbiomics, and machine learning), and the integration of multi-dimentional measures. With the accomplishment of this project, we will establish the most comprehensive ASD bio-bank in Asia, develop ASD NGS panel, identify several ASD biomarkers, publish at least 15 SCI papers in total, and in the end, have patents registration and technology transfer of our precise objective, automated assessment system for ASD. Our findings will further advance our understanding of ASD, ultimately contribute to the early detection, diagnosis, and treatment of ASD, and be the first step of precise medicine for ASD.
Detailed description
Autism spectrum disorder (ASD) is a common highly heritable neurodevelopmental disorder with high genetic and clinical heterogeneity. Due to its high prevalence, long-term impairment, unclear etiologies, and a lack of effective detection, prevention and biological treatment for this disorder, this catastrophic disorder has been prioritized for molecular genetic and brain research. The main PI Gau has established a cohort of more than 900 ASD probands and their families with clinical, neuropsychological, image, and genetic data. With the advance in digit health, this integrated project aims to develop and potentially commercialize an objective, automated assessment system for early diagnosis of ASD based on the clinical, behavioral, neuropsychological, neuroimaging, genetic (whole exome sequencing, WES), metabolomics, and microbiomics data of probands with ASD and typically developing controls(TDC) without ASD
This 3-year, 5 subprojects (SP) project is based on an existing big cohort of > 900 ASD probands and their families with high-quality genetic data, clinical diagnoses, symptoms, psychopathology, social functions, neuropsychological functions (n= 600 for CPT, 300 for CANTAB), and structural and functional images (n=196), data. Due to a limited budget, SP1 will only select 360 ASD (ages 4-25 years old) and 90 TDC for this integrated project. SP1 will check the quality and presence of the data followed by recollecting DNAs of 100 ASD, MRI data of 205 ASD (360-196=164, 164/0.8(successful rate)=205), and CANTAB of 60 ASD to have a complete dataset of clinical/phenotype/neurocognition/image measures. SP1 will prepare DNAs for SP2's WES analyses; and will collect serum and stool of 360 ASD and 90 TDC and provide these samples to SP3 and SP4 for metabolomics and microbiomics analyses, respectively. All the data collected and results generated from SP1-4 will be saved and managed in the ASD bank (SP1, main PI) and analyzed by SP5 using AI machine learning to develop the precise objective automatic assessment platform for ASD. The topics of the five subprojects:
Subproject 1. Establishing the standard procedure for data collection and clinical-biological bank of autism spectrum disorder including clinical, behavioral, cognitive, neuroimaging, genetic, and biological data Subproject 2. Deciphering genetic cause in autistic spectrum disorder using whole exome sequencing Subproject 3. Metabolomics investigation of Autism Spectrum Disorder Subproject 4. Intestinal microbiota and disease outcome in children with autism spectrum disorder Subproject 5. A computerized assessment system from genome, gut-brain, and metabolic mechanisms
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Other: Psychiatric diagnosis, Other: ASD diagnosis450 ASD from cohort established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007. |
| TD group | – | Other: Psychiatric diagnosis100 healthy typical developing control (TDC) from cohort established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007. |
Who may qualify
- Ages
- 4 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The cohort was established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007. No less than 450 ASD and 100 healthy typical developing control (TDC) would be selected from the original cohort.
Key inclusion criteria (3 listed)
- Clinical diagnosis of ASD defined by the DSM-IV confirmed by ADI-R or ADOS
- At least one biological parent
- Parents are both Han Chinese in Taiwan
Key exclusion criteria (3 listed)
- Schizophrenia
- Schizoaffective disorder
- Organic psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric diagnosisKiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5 | Other | ASD group, TD group |
| ASD diagnosisAutism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS) | Other | ASD group |
Primary outcome
Autism diagnostic interview (ADI-R)
Time frame: 4 hours
Including reciprocal social interaction, communication, and repetitive behaviors and stereotyped patterns, for children with a mental age from about 18 months into adulthood
Neuropsychological functions: Continuous Performance Test(CPT)
Time frame: 15 minutes
The 4 dimensions of CCPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance
Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)
Time frame: 1.5 hours
The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism diagnostic interview (ADI-R) (time frame: 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.