Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 17, 2014
Last verified: November 2014

October 23, 2012
November 17, 2014
October 2012
November 2015   (final data collection date for primary outcome measure)
RNA gene expression in peripheral blood [ Time Frame: within 30 days of collection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01716845 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
SynapDx Autism Gene Expression Analysis Study
SynapDx Autism Spectrum Disorder Gene Expression Analysis Study

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

DNA, RNA

Probability Sample

Children 18 months to < 5 years referred to a developmental evaluation centers for evaluation of a possible developmental disorder.

Autism
Not Provided
  • Development group 1
  • Development group 2
  • Development group 3
  • Validation group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
660
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01716845
12001
No
SynapDx
SynapDx
Not Provided
Not Provided
SynapDx
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP