SynapDx Autism Gene Expression Analysis Study (STORY)
This study will prospectively enroll approximately 880 children, at least 18 months and less than 60 months of age, who have been referred to a pediatric developmental evaluation center. 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 primary objective of this study is:
- 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).
|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:||March 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
In the Development Phase, analyses will be performed until the classification algorithm is finalized.
The Validation Phase will assess the performance of the finalized classification algorithm in 300 subjects.
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|Study Director:||Stan Lapidus||SynapDx Corp|