NCT02832557

A Salivary miRNA Diagnostic Test for Autism

Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 998 (actual)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 24 Months – 48 Months
• Healthy volunteers: Accepted

Summary

The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.

Detailed description

The central aim of this project is to validate a panel of expressed microRNA (miRNA) in the saliva of children identified at risk for developing ASD by the MCHAT-R. Further, this study aims to assess the value of the current panel as an adjunctive test that may increase specificity of MCHAT-R positive results, or affirm clinical diagnoses alongside the ADOS or other objective assessments. The primary endpoints of this study are as follows: 1. Evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary microtranscriptome panel for distinguishing children with ASD from their non-ASD peers. 2. Assess stability of the salivary microtranscriptome diagnosis over time, and interrogate longitudinal microtranscriptome levels relative to neuropsychological measures. Secondary endpoints are the identification of microtranscriptome features whose concentrations correlate with ASD endophenotypes.

Conditions

• Autism Spectrum Disorder
• Developmental Delay

Interventions

Type	Name	Description
OTHER	Salivary collection	Collection of saliva via swab for miRNA processing
OTHER	Vineland Adaptive Behavior Scale-III Assessment
OTHER	Medical history questionaire
OTHER	Autism Diagnostic Observation Schedule -2nd edition (ADOS-2)
OTHER	Mullen Scales of Early Learning

Timeline

• Start date: 2015-11-01
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2016-07-14
• Last updated: 2023-06-05

Locations

1 site across 1 country: United States