Clinical Trial: Exosomal MicroRNA Expression in Children With Autism Spectrum Disorder
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Exosomal MicroRNA Expression in Children With Autism Spectrum Disorder
Brief Summary:
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.
Detailed Summary:
This study will recruit 20 children with idiopathic ASD (defined by DSM-IV criteria) and 20 age- and gender-matched controls with typical neuropsychological developmental patterns. The number of subjects necessary for this study was determined by power analysis. Using a two sample t-test model with 15 ASD and 15 control subjects in each group would have 80% power to detect changes in expression equal to twice the standard deviation of the group mean with Bonferonni corrected level (p<0.0001) based on expectations of measuring 500 miRNA in each sample (Lenth, 2006).
Parental consent and patient assent forms will be distributed to potential subjects at the University Pediatric and Adolescent Center and the Center for Development Behavior and Genetics. To explain the study, children will be told, "The doctors are doing a study about a disease called autism. If you want to be in this study a small amount of blood will be taken from your arm with a needle. The needle will hurt but will go away after a little while. The doctors will ask you to answer some questions about how you feel. You do not have to be in the study. No one will be mad at you if you don't want to do this."
ASD subjects will be assessed using current methods in autism diagnosis: the Autism Diagnostic Observation Schedule (ADOS) and the Checklist for Autism in Toddlers (CHAT). The Vineland Behavior Scales will also be administered. All medical information collected will be coded and de-identified according to standard protocols.
Venipuncture will be employed to collect 2ml of blood from each subject into an EDTA-free vacutainer tube. Samples will be left for 1 hour at 37˚C to allow clotting before storage at 4˚C overnight. The sample will then be centrifuged at 4000 rpm for 20 minutes at 4
Sponsor: State University of New York - Upstate Medical University
Current Primary Outcome: Exosomal microRNA expression patterns [ Time Frame: 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: State University of New York - Upstate Medical University
Dates:
Date Received: December 12, 2012
Date Started: January 2013
Date Completion:
Last Updated: November 25, 2014
Last Verified: November 2014
