Autism
Conditions
Keywords
autism, autism spectrum disorders, RNA, gene expression, developmental delay
Brief summary
This study will prospectively enroll approximately 660 children, at least 18 months and less than 5 years of age, who have been referred to a pediatric developmental evaluation centers. Enrolled children will have blood drawn for RNA gene expression analysis and undergo a clinical evaluation to determine the presence or absence of a diagnosis of ASD. The sequential co-primary objectives of this study are: * To develop an algorithm to classify blood RNA gene expression patterns to maximize agreement between the classification and a clinical assessment of presence or absence of Autism Spectrum Disorders (ASD). * To prospectively assess the clinical sensitivity and specificity of the blood RNA gene expression classification algorithm (the SDX-002 test) in children referred to a developmental evaluation clinic for a possible developmental disorder.
Interventions
None listed
Sponsors
SynapDx
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
1. Referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems. 2. Age \>= 18 months and \< 5 years. 3. Parent/legal guardian has been informed about the study and has signed an informed consent form.
Exclusion criteria
1. Prior reliable diagnosis of Autism Spectrum Disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established Autism Spectrum Disorder diagnosis). 2. Unable or unwilling to complete study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RNA gene expression in peripheral blood | within 30 days of collection |
Countries
United States
Outcome results
None listed