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

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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).


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
2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
Miller Children's Hospital Miller Children
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300 Longwood Avenue
Boston, Massachusetts 02115
617-355-6000
Children's Hospital - Boston Boston Children's Hospital is a 395-bed comprehensive center for pediatric health...
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Boston, MA
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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3333 Burnet Avenue # Mlc3008
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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Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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171 Ashley Avenue
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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Charleston, SC
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Chicago, Illinois 60612
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Chicago, IL
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Decatur, Georgia 30033
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Decatur, GA
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Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Lexington, Massachusetts 02421
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Lexington, MA
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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New York, NY
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Sacramento, California 95817
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Sacramento, CA
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Scottsdale, Arizona 85254
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Seattle, Washington 98115
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Staten Island, NY
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