Autism Spectrum DisorderNCT04358744
The Real World Study of Autism Spectrum Disorder in China
An observational study of Autism Spectrum Disorder, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The investigators conduct the real world study to explore mechanisms of autism based on multi-modal data. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2019to Sep 2024
- How long will I take part?
- 1 Year
- 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 18 months to 18 years
- All sexes
- Child, Adult
Study population: Children with autism spectrum disorder have registered in Xinhua hospital and provided written informed consent from themselves and/or their legal guardians.
Who may be able to join
- diagnosed with autism spectrum disorder
- registered in Xinhua hospital
- written informed consent provided
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ShanghaiXinhua
Shanghai, Shanghai Municipality, 200092
Fei Li, Director
About this study
Official title: The Real World Study of Children With Autism Spectrum Disorder in China
The investigators conduct the real world study to explore mechanisms of autism based on multi-modal data.
Read the detailed description
Children with autism spectrum disorder registered in Xinhua Hospital are measured in aspects of behavioural accessment, genetic test, blood lab test, gut microbiome and neuroimaging including structural and functional magnetic resonance imaging (MRI), functional near - infrared spectroscopy(f-NIRS), electroencephalography and eye movement. The investigators conduct the real world study to explore mechanisms of autism based on the multi-modal data.
- Conditions
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviour assessment
The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.
Measured: The baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start13 Apr 2019
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
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 Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Li, doctor, Principal investigator, Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358744
- Sponsor's protocol ID
- XH-20-005
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real World Study of Children With Autism Spectrum Disorder in China
- ClinicalTrials.gov ID
- NCT04358744
- Acronym / sponsor ID
- XH-20-005
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 24 Apr 2020 (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 investigators conduct the real world study to explore mechanisms of autism based on multi-modal data.
Detailed description
Children with autism spectrum disorder registered in Xinhua Hospital are measured in aspects of behavioural accessment, genetic test, blood lab test, gut microbiome and neuroimaging including structural and functional magnetic resonance imaging (MRI), functional near - infrared spectroscopy(f-NIRS), electroencephalography and eye movement. The investigators conduct the real world study to explore mechanisms of autism based on the multi-modal data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with autism spectrum disorder have registered in Xinhua hospital and provided written informed consent from themselves and/or their legal guardians.
Key inclusion criteria (3 listed)
- diagnosed with autism spectrum disorder
- registered in Xinhua hospital
- written informed consent provided
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Behaviour assessment
Time frame: The baseline and 3 months
The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Fei Li, doctor principal investigator
Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
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 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Oct 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Li, doctor (+86-21-25077461, feili@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behaviour assessment (time frame: The baseline and 3 months). 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 29 Oct 2021.