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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
  Purpose

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).


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

Peripheral blood


Estimated Enrollment: 880
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  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: NCT01810341

  Show 20 Study Locations
Sponsors and Collaborators
SynapDx
Investigators
Study Director: Stan Lapidus SynapDx Corp
  More Information

No publications provided

Responsible Party: SynapDx
ClinicalTrials.gov Identifier: NCT01810341     History of Changes
Other Study ID Numbers: 12002
Study First Received: March 11, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

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 August 27, 2014