SynapDx Autism Gene Expression Analysis Study (SAGA)
|ClinicalTrials.gov Identifier: NCT01716845|
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : December 17, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||660 participants|
|Official Title:||SynapDx Autism Spectrum Disorder Gene Expression Analysis Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|Development group 1|
|Development group 2|
|Development group 3|
- RNA gene expression in peripheral blood [ Time Frame: within 30 days of collection ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716845
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|