Autism Spectrum DisorderNCT05439954
Radiomics of Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Qingling Chen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Dec 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 1 year to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital at Sun Yat-sen University
Zhuhai, Guangdong
About this study
Official title: Application of MRI Radiomics to Improve Diagnosis and Pharmacologica Prognosis of Autism Spectrum Disorder
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
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of autism spectrum disorder
differential diagnosis of case group and control group
Measured: 01/12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jan 2020
- Primary completion1 Jun 2022
- Study completion1 Dec 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.
- 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
- Other
- Enrolment
- 230 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Qingling Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qingling Chen, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439954
- Sponsor's protocol ID
- QL Chen
- Status last verified
- Feb 2024
- First submitted
- 27 Jun 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of MRI Radiomics to Improve Diagnosis and Pharmacologica Prognosis of Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05439954
- Acronym / sponsor ID
- QL Chen
- Conditions
- Autism Spectrum Disorder
- Keywords
- MRI, radiomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Qingling ChenUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Jun 2022 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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
diagnosis of autism spectrum disorder
Time frame: 01/12/2022
differential diagnosis of case group and control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- 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.
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 Qingling Chen 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 0 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 23 Feb 2024. 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?
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?
diagnosis of autism spectrum disorder (time frame: 01/12/2022). 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 23 Feb 2024.