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SynapDx Autism Gene Expression Analysis Study (SAGA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SynapDx
ClinicalTrials.gov Identifier:
NCT01716845
First received: October 23, 2012
Last updated: March 8, 2013
Last verified: March 2013
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
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
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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:

  1. Referred to a developmental evaluation centers for evaluation of a possible developmental disorder, other than isolated motor problems.
  2. Age >= 18 months and < 5 years.
  3. Parent/legal guardian has been informed about the study and has signed an informed consent form.

Exclusion Criteria:

  1. Prior reliable diagnosis of Autism Spectrum Disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established Autism Spectrum Disorder diagnosis).
  2. Unable or unwilling to complete study procedures
  Contacts and Locations
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: March 8, 2013
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 Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013