SynapDx Autism Gene Expression Analysis Study (STORY)
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/8/2014 |
| Start Date: | March 2013 |
| End Date: | September 2014 |
SynapDx Autism Spectrum Disorder Gene Expression Analysis Study
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 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 primary objective of this study is:
- 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).
than 60 months of age, who have been referred to a pediatric developmental evaluation
center. 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 primary objective of this study is:
- 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).
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
18
sites
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Children's Hospital - Boston Boston Children's Hospital is a 395-bed comprehensive center for pediatric health...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Miller Children's Hospital Miller Children
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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