NCT04358744

Brief Summary

The investigators conduct the real world study to explore mechanisms of autism based on multi-modal data.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 29, 2021

Status Verified

April 1, 2021

Enrollment Period

5.4 years

First QC Date

April 20, 2020

Last Update Submit

October 27, 2021

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • Behaviour assessment

    The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.

    The baseline and 3 months

Other Outcomes (21)

  • Genetic characteristics

    The baseline

  • Blood test

    The baseline and 3 months

  • Blood test

    The baseline and 6 months

  • +18 more other outcomes

Eligibility Criteria

Age18 Months - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ShanghaiXinhua

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and stool samples are retained in Xinhua

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Fei Li, doctor

    Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Li, doctor

CONTACT

+86-21-25077461feili@shsmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

April 13, 2019

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

October 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)