SynapDx Autism Gene Expression Analysis Study (SAGA)
This study has been completed.
Sponsor:
SynapDx
Information provided by (Responsible Party):
SynapDx
ClinicalTrials.gov Identifier:
NCT01716845
First received: October 23, 2012
Last updated: December 15, 2014
Last verified: December 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Autism |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | SynapDx Autism Spectrum Disorder Gene Expression Analysis Study |
Resource links provided by NLM:
Further study details as provided by SynapDx:
Primary Outcome Measures:
- RNA gene expression in peripheral blood [ Time Frame: within 30 days of collection ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
DNA, RNA
| Estimated Enrollment: | 660 |
| Study Start Date: | October 2012 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Development group 1 |
| Development group 2 |
| Development group 3 |
| Validation group |
Eligibility| Ages Eligible for Study: | 18 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Children 18 months to < 5 years referred to a developmental evaluation centers for evaluation of a possible developmental disorder.
Criteria
Inclusion Criteria:
- Referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems.
- Age >= 18 months and < 5 years.
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716845
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716845
Locations
| United States, Massachusetts | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
SynapDx
More Information
No publications provided
| Responsible Party: | SynapDx |
| ClinicalTrials.gov Identifier: | NCT01716845 History of Changes |
| Other Study ID Numbers: | 12001 |
| Study First Received: | October 23, 2012 |
| Last Updated: | December 15, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by SynapDx:
|
autism autism spectrum disorders RNA gene expression developmental delay |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Mental Disorders Diagnosed in Childhood |
ClinicalTrials.gov processed this record on February 25, 2015