Autism Spectrum Disorder Clinical Trial
Official title:
Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
Verified date | June 2023 |
Source | State University of New York - Upstate Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.
Status | Completed |
Enrollment | 998 |
Est. completion date | August 31, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 24 Months to 48 Months |
Eligibility | Inclusion Criteria: - Age at enrollment: 24 months to 48 months (inclusive) - MCHAT-R score of 3 or greater - Parent/guardian must be fluent in spoken English (required to complete study specific questionnaires etc) Exclusion Criteria: - confounding neurological (i.e. cerebral palsy, epilepsy), sensory (i.e. auditory or visual) impairments, and feeding tube dependence. - history of extreme pre-term birth (< 32 weeks gestation) - wards of the state - Autistic subjects with known syndromic autism (attributed to a known genetic mutation) |
Country | Name | City | State |
---|---|---|---|
United States | SUNY Upstate Medical University | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York - Upstate Medical University | Baylor College of Medicine, Children's Hospital Medical Center, Cincinnati, Milton S. Hershey Medical Center, National Institute of Mental Health (NIMH), Quadrant Biosciences Inc., University of Missouri-Columbia |
United States,
Hicks SD, Ignacio C, Gentile K, Middleton FA. Salivary miRNA profiles identify children with autism spectrum disorder, correlate with adaptive behavior, and implicate ASD candidate genes involved in neurodevelopment. BMC Pediatr. 2016 Apr 22;16:52. doi: 10.1186/s12887-016-0586-x. — View Citation
Hicks SD, Rajan AT, Wagner KE, Barns S, Carpenter RL, Middleton FA. Validation of a Salivary RNA Test for Childhood Autism Spectrum Disorder. Front Genet. 2018 Nov 9;9:534. doi: 10.3389/fgene.2018.00534. eCollection 2018. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Salivary miRNA profile | Measures of miRNA abundance in saliva | at the time of collect (from 18m to 6 years of age) | |
Secondary | Measures of adaptive function | Vineland Adaptive Behavior Composite Score | At time of enrollment (from 18m to 6 years of age) | |
Secondary | Measures of early intellectual development | Mullen Scales of Early Learning | At time of enrollment (from 18m to 6 years of age) | |
Secondary | Measure of autistic behavior | Autism Diagnostic Observation Schedule (ADOS) Composite Score (Autism Group Only) | At time of enrollment (from 18m to 6 years of age) |
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