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SynapDx Autism Gene Expression Analysis Study (STORY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by SynapDx
Sponsor:
Information provided by (Responsible Party):
SynapDx
ClinicalTrials.gov Identifier:
NCT01810341
First received: March 11, 2013
Last updated: January 22, 2014
Last verified: January 2014

March 11, 2013
January 22, 2014
March 2013
July 2014   (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 NCT01810341 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
SynapDx Autism Gene Expression Analysis Study (STORY)
SynapDx Autism Spectrum Disorder Gene Expression Analysis Study

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 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).

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

Peripheral blood

Probability Sample

Children 18 months to less than 60 months referred to a developmental evaluation center for evaluation of a possible developmental disorder.

Autism
Not Provided
  • Development Group
    In the Development Phase, analyses will be performed until the classification algorithm is finalized.
  • Validation Group
    The Validation Phase will assess the performance of the finalized classification algorithm in 300 subjects.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
880
September 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Referred to a developmental evaluation center for evaluation of a possible developmental disorder, other than isolated motor problems.
  • At least 18 months and less than 60 months.
  • 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.
Both
18 Months to 60 Months
No
United States,   Canada
 
NCT01810341
12002
No
SynapDx
SynapDx
Not Provided
Study Director: Stan Lapidus SynapDx Corp
SynapDx
January 2014

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