Radiomics of Autism Spectrum Disorder

NCT05439954 | Active Not Recruiting

• 1 other identifier: QL Chen
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Autism Spectrum Disorder (ASD) refers to a group of neurodevelopmental disorders including autism.Despite ongoing studies, the pathogenesis of ASD still remains unclear.The global prevalence of ASD was estimated at 1% in 2015.The diagnostic criteria for ASD are specified in the DSM ( American Psychiatric Association, 2013 ) and serve as guideline for clinicians at the present. However, its early diagnosis value is limited due to a high subjectivities and its low diagnostic sensitivity and specificity.Early detection and early pharmacological and behavioral interventions are critical in improving the symptoms and preventing the disease progression. There are no medications that directly treat the core symptoms present in individuals with ASD, and the effectiveness of interventions remains limited. Therefore, accurate assessment of pharmacological efficacy is necessary for the reatment, and prognostication of individuals with ASD. Magnetic resonance imaging (MRI) is a commonly used imaging tool for clinical disease diagnosis, especially for neurological disorders. Besides, Structural Magnetic Resonance imaging reflects neuropathological and microstructural developmental changes during growth. Radiomics based on the high-dimensional quantitation of medical images, allowing extraction of more detailed characteristics than is possible with conventional visual interpretation. This study aims: (1)To explore an objective diagnostic method through radiomics in children with ASD (2)to provide prognostic estimates of the outcome, based on estimates of an individual patient's prognosis and the efficacy of different drug therapies.

Conditions

Autism Spectrum Disorder

Keywords

MRI; radiomics

Outcome Measures

Primary Outcomes (1)

• diagnosis of autism spectrum disorder

  differential diagnosis of case group and control group

  01/12/2022

Study Arms (2)

Case group

（a）patients fulfilling the Diagnostic Criteria of the Diagnostic and Statistical Manual of Mental Disorders 5th Edition（DSM-V); (b)age:14 and under 14 years old; (c)first clinic visit, never-treated; (d)without injury to head and other diseases of the nervous system.

Control Group

（a）healthy subject of same ages;(b)without injury to head and diseases of the nervous system; (c)without family history of mental disorders; (d)without other somatic illness.

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

（a）patients fulfilling the Diagnostic Criteria of the Diagnostic and Statistical Manual of Mental Disorders 5th Edition（DSM-V); (b)age:14 and under 14 years old; (c)first clinic visit, never-treated; (d)without injury to head and other diseases of the nervous system.

Sponsors & Collaborators

• Qingling Chen: lead

Study Sites (1)

The Fifth Affiliated Hospital at Sun Yat-sen University

Zhuhai, Guangdong, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: January 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)