SynapDx Autism Gene Expression Analysis Study (STORY)
Public ClinicalTrials.gov record NCT01810341. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
SynapDx Autism Spectrum Disorder Gene Expression Analysis Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 optionally for metabolite, lipid and DNA 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). The secondary objectives of this study are: * To develop an algorithm to classify plasma metabolite and/or lipid profiles in such a way as to maximize agreement between the classification and a clinical assessment of presence or absence of ASD. * To prospectively assess the clinical sensitivity and specificity of the plasma metabolite and/or lipid profile classification algorithm in a separate population consisting of children referred to a developmental evaluation clinic for a possible developmental disorder (DD). * To evaluate clinical sensitivity and specificity of various combinations of gene expression signature, metabolite and/or lipid signatures, and presence of ASD-associated genetic variation detected by chromosomal microarray analysis (CMA) or sequencing protein-coding regions of the genome.
Study identification
- NCT ID
- NCT01810341
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 880 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Months to 60 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2013 (Type not available)
- Primary completion
- Jul 2014 (Actual)
- Completion
- Dec 2014 (Actual)
- Last update posted
- Dec 17, 2014
2013 – 2014
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Melmed Center | Scottsdale | Arizona | 85254 | — |
| Miller Children's Hospital | Long Beach | California | 90806 | — |
| UC Davis MIND Institute | Sacramento | California | 95817 | — |
| Emory University | Decatur | Georgia | 30033 | — |
| Rush Medical Center | Chicago | Illinois | 60612 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| Lurie Center Massachusetts General Hospital | Lexington | Massachusetts | 02421 | — |
| Mount Sinai School of Medicine/Seaver Center | New York | New York | 10029 | — |
| Institute for Behavioral Research on Staten Island | Staten Island | New York | 10314 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27517 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University | Nashville | Tennessee | 37212 | — |
| Baylor College of Medicine/Texas Children's Hospital | Houston | Texas | 77054 | — |
| Seattle Children's | Seattle | Washington | 98121 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01810341, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 17, 2014 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01810341 live on ClinicalTrials.gov.