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Exosomal MicroRNA Expression in Children With Autism Spectrum Disorder

This study is not yet open for participant recruitment.
Verified December 2012 by State University of New York - Upstate Medical University
Sponsor:
Information provided by (Responsible Party):
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01749670
First received: December 12, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

There is accumulating evidence that genetic expression plays a role in autism spectrum disorder, but the regulation of such genes is poorly understood. Small RNA particles, called microRNA (miRNA), have the ability to alter gene expression. These particles can be packaged and released from brain cells into the blood. Changes in miRNA may contribute to the patterns observed in autism spectrum disorder.

The purpose of this study is to identify small RNA particles that regulate gene expression in autism spectrum disorder. The goal is to identify miRNA expression patterns which may improve our understanding and diagnosis of autism spectrum disorder.


Condition
Autism Spectrum Disorder
Exosomal miRNA Expression

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Exosomal microRNA expression patterns [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole Blood


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Autism
Children ages 4-17 years old with DSM-IV defined autism spectrum disorder
Control
Age- and gender-matched controls with typical neuropsychological developmental patterns

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children from the University Pediatric and Adolescent Center and the Center for Development Behavior and Genetics in Syracuse, New York.

Criteria

Inclusion Criteria:

  • Children ages 4-17

Exclusion Criteria:

  • neurological impairments (i.e. cerebral palsy, epilepsy)
  • sensory deficits (i.e. sensory or visual impairments)
  • psychological disorders (i.e. obsessive compulsive disorder, attention deficit disorder)
  • control subjects with family history of autism spectrum disorder
  • mental retardation
  • history of preterm birth
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749670

Contacts
Contact: Steven Hicks, MD, PhD 845 518 0649 hickss@upstate.edu

Locations
United States, New York
SUNY Upstate Medical University Not yet recruiting
Syracuse, New York, United States, 13210
Contact: Steven Hicks, MD, PhD     845-518-0649     hickss@upstate.edu    
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Steven Hicks, MD, PhD SUNY Upstate Medical University, Department of Pediatrics
  More Information

No publications provided

Responsible Party: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01749670     History of Changes
Other Study ID Numbers: 346301-1
Study First Received: December 12, 2012
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by State University of New York - Upstate Medical University:
Autism Spectrum Disorder
Exosomal miRNA expression

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013