SynapDx Autism Gene Expression Analysis Study

Completed

• Conditions: Autism

• Registration Number: NCT01716845
• Lead Sponsor: SynapDx

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-30
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RNA gene expression in peripheral blood	within 30 days of collection

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States