SynapDx Autism Gene Expression Analysis Study (SAGA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

SynapDx

ClinicalTrials.gov Identifier:

NCT01716845

First received: October 23, 2012

Last updated: December 15, 2014

Last verified: December 2014

History of Changes

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:

MedlinePlus related topics: Autism Spectrum Disorder Genes and Gene Therapy

U.S. FDA Resources

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 (Child)
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

Locations


United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

SynapDx

More Information


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 Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 26, 2016

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