A Salivary miRNA Diagnostic Test for Autism
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|ClinicalTrials.gov Identifier: NCT02832557|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : July 19, 2016
|Condition or disease||Intervention/treatment|
|Autism Spectrum Disorder Developmental Delay||Other: Salivary collection Other: Vineland Adaptive Behavior Scale-II Assessment Other: Medical history questionaire Other: Autism Diagnostic Observation Schedule -2nd edition (ADOS-2)|
The central aim of this project is to characterize the expression of microRNA (miRNA) in the saliva of children with autism spectrum disorder (ASD). In 2012 the CDC reported that the prevalence of ASD in U.S. children was 1 in 88. Yet, the biological causes, diagnosis, and treatment of this disease remain ambiguous. Recent research suggests that certain factors that regulate gene expression may play a role in ASD. To investigate this possibility we plan to measure small molecules called miRNAs in the saliva of children with ASD. Studies on miRNAs have shown that they can be extruded from neurons as extracellular signaling molecules and this knowledge provides a new approach for examining the genetic regulation of the central nervous system.
In this study we are measuring the expression of extracellular miRNA in children with ASD. Levels of miRNA from saliva will be compared to those of normally developing controls. The goal of this research will be to provide possible biomarkers for diagnostic screening of ASD and identify genetic regulatory mechanisms involved in ASD.
The primary endpoints of this study are as follows:
- Characterization of miRNA in the saliva of children with ASD and normally developing control children from two to six years of age.
- Identification of miRNAs in saliva that are predictive of ASD diagnosis and severity of symptoms.
Secondary endpoints are the identification of miRNA expression patterns that correlate with ASD symptom severity measured with standardized neuropsychologic testing.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Observational Model:||Case Control|
|Official Title:||Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Autism Spectrum Disorder (ASD)
Children with autism spectrum disorder (ASD), diagnosed using DSM-5 criteria and confirmed with ADOS or another semi-structured evaluation measure. ASD should not be attributable to an underlying genetic abnormality, and participants should not have a history of extreme pre-term birth or underlying neurological disorders such as seizures or cerebral palsy.
Other: Salivary collection
Collection of saliva via swab for miRNA processingOther: Vineland Adaptive Behavior Scale-II Assessment Other: Medical history questionaire Other: Autism Diagnostic Observation Schedule -2nd edition (ADOS-2)
Children from 2 to 6 years of age with normal developmental milestones.
Other: Salivary collection
Collection of saliva via swab for miRNA processingOther: Vineland Adaptive Behavior Scale-II Assessment Other: Medical history questionaire
- Salivary miRNA profile [ Time Frame: at the time of collect (from 2 to 6 years of age) ]Measures of miRNA abundance in saliva
- Measures of adaptive function [ Time Frame: At time of enrollment (from 2 to 6 years of age) ]Vineland Adaptive Behavior Composite Score
- Measure of autistic behavior [ Time Frame: At time of enrollment (from 2 to 6 years of age) ]Autism Diagnostic Observation Schedule (ADOS) Composite Score (Autism Group Only)
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832557
|Contact: Frank Middleton, PhDfirstname.lastname@example.org|
|United States, New York|
|SUNY Upstate Medical University||Recruiting|
|Syracuse, New York, United States, 13210|
|Contact: Frank A Middleton, PhD 315-464-7729 email@example.com|
|Principal Investigator: Frank Middleton A Middleton, PhD|