SynapDx Autism Gene Expression Analysis Study

Autism Clinical Trial

— SAGA  

Official title:

SynapDx Autism Spectrum Disorder Gene Expression Analysis Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716845
• Other study ID #: 12001
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: December 15, 2014
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: SynapDx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 5 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
SynapDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RNA gene expression in peripheral blood		within 30 days of collection	No