SynapDx Autism Gene Expression Analysis Study
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | October 2012 |
| End Date: | April 2014 |
SynapDx Autism Spectrum Disorder Gene Expression Analysis Study
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.
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
We found this trial at
1
site
Children's Hospital - Boston Boston Children's Hospital is a 395-bed comprehensive center for pediatric health...
Click here to add this to my saved trials
