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Exosomal MicroRNA Expression in Children With Autism Spectrum Disorder

This study has been completed.
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: November 25, 2014
Last verified: November 2014
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Exosomal MicroRNA Expression in Children With Autism Spectrum Disorder

Resource links provided by NLM:


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


Enrollment: 45
Study Start Date: January 2013
Study Completion Date: September 2014
Primary Completion Date: September 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
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: NCT01749670

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
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: November 25, 2014
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
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014