Status:
COMPLETED
SynapDx Autism Gene Expression Analysis Study (STORY)
Lead Sponsor:
SynapDx
Conditions:
Autism
Eligibility:
All Genders
18-60 years
Brief Summary
This study will prospectively enroll approximately 880 children, at least 18 months and less than 60 months of age, who have been referred to a pediatric developmental evaluation center. Enrolled chil...
Detailed Description
The primary aim of this study is to define a gene expression signature indicative of ASD and to establish its clinical sensitivity and specificity. Clinician diagnosis of ASD will be made using DSM-5 ...
Eligibility Criteria
Inclusion
- Referred to a developmental evaluation center for evaluation of a possible developmental disorder, other than isolated motor problems.
- At least 18 months and less than 60 months.
- Parent/legal guardian has been informed about the study and has signed an informed consent form.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT01810341
Start Date
March 1 2013
End Date
December 1 2014
Last Update
December 17 2014
Active Locations (20)
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1
Melmed Center
Scottsdale, Arizona, United States, 85254
2
Miller Children's Hospital
Long Beach, California, United States, 90806
3
UC Davis MIND Institute
Sacramento, California, United States, 95817
4
Emory University
Decatur, Georgia, United States, 30033