SynapDx Autism Gene Expression Analysis Study (SAGA)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||SynapDx Autism Spectrum Disorder Gene Expression Analysis Study|
- RNA gene expression in peripheral blood [ Time Frame: within 30 days of collection ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Development group 1|
|Development group 2|
|Development group 3|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716845
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|