The Real World Study of Autism Spectrum Disorder in China

October 27, 2021 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • ShanghaiXinhua
        • Contact:
          • Fei Li, Director

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 14 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with autism spectrum disorder have registered in Xinhua hospital and provided written informed consent from themselves and/or their legal guardians.

Description

Inclusion Criteria:

  • diagnosed with autism spectrum disorder
  • registered in Xinhua hospital
  • written informed consent provided

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Behaviour assessment
Time Frame: The baseline and 3 months
The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.
The baseline and 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Genetic characteristics
Time Frame: The baseline
Genome wide association study from blood sample
The baseline
Blood test
Time Frame: The baseline and 3 months
Retained blood samples tested in immunomics, metabonomics, etc
The baseline and 3 months
Blood test
Time Frame: The baseline and 6 months
Retained blood samples tested in immunomics, metabonomics, etc
The baseline and 6 months
Blood test
Time Frame: The baseline and 12 months
Retained blood samples tested in immunomics, metabonomics, etc
The baseline and 12 months
Gut mircobiome
Time Frame: The baseline and 1 months
Retained stool samples tested in metabonomics, genomics, etc
The baseline and 1 months
Gut mircobiome
Time Frame: The baseline and 3 months
Retained stool samples tested in metabonomics, genomics, etc
The baseline and 3 months
Gut mircobiome
Time Frame: The baseline and 6 months
Retained stool samples tested in metabonomics, genomics, etc
The baseline and 6 months
Gut mircobiome
Time Frame: The baseline and 12 months
Retained stool samples tested in metabonomics, genomics, etc
The baseline and 12 months
Head Magnetic Resonance Imaging (Head MRI)
Time Frame: The baseline and 3 months
Head MRI is used to detect the structure and function of the brain.
The baseline and 3 months
Head Magnetic Resonance Imaging (Head MRI)
Time Frame: The baseline and 12 months
Head MRI is used to detect the structure and function of the brain.
The baseline and 12 months
Functional near - infrared spectroscopy(f-NIRS)
Time Frame: The baseline and 3 months
Head fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity. It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range.
The baseline and 3 months
Functional near - infrared spectroscopy(f-NIRS)
Time Frame: The baseline and 6 months
Head fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity. It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range.
The baseline and 6 months
Functional near - infrared spectroscopy(f-NIRS)
Time Frame: The baseline and 12 months
Head fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity. It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range.
The baseline and 12 months
Multichannel Electroencephalography signals
Time Frame: The baseline and 3 months
The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.
The baseline and 3 months
Multichannel Electroencephalography signals
Time Frame: The baseline and 6 months
The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.
The baseline and 6 months
Multichannel Electroencephalography signals
Time Frame: The baseline and 12 months
The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.
The baseline and 12 months
Eye movements
Time Frame: The baseline and 3 months
Variables measured by eye movements represent cognition.
The baseline and 3 months
Eye movements
Time Frame: The baseline and 6 months
Variables measured by eye movements represent cognition.
The baseline and 6 months
Eye movements
Time Frame: The baseline and 12 months
Variables measured by eye movements represent cognition.
The baseline and 12 months
Behaviour assessment
Time Frame: The baseline and 6 months
The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.
The baseline and 6 months
Behaviour assessment
Time Frame: The baseline and 12 months
The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.
The baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fei Li, doctor, Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XH-20-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism Spectrum Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings