SynapDx Autism Gene Expression Analysis Study
Completed
Conditions studied: Autism
In brief
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.
Key facts
- Study ID
- NCT01716845
- Run by
- SynapDx
- People needed
- 660
- Starts
- 2012-10-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2014-12-17
Who can join
Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems.
- Age >= 18 months and < 5 years.
- Parent/legal guardian has been informed about the study and has signed an informed consent form.
You may not qualify if…
- Prior reliable diagnosis of Autism Spectrum Disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established Autism Spectrum Disorder diagnosis).
- Unable or unwilling to complete study procedures
Where it is running
- Children's Hospital Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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