A Salivary miRNA Diagnostic Test for Autism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02832557|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment|
|Autism Spectrum Disorder Developmental Delay||Other: Salivary collection 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|
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:
- Evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary microtranscriptome panel for distinguishing children with ASD from their non-ASD peers.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official Title:||Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder|
|Actual Study Start Date :||November 1, 2015|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Children identified at risk for the development of autism spectrum disorder (ASD) by scoring a 3 or higher on the MCHAT-R. 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 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
- Salivary miRNA profile [ Time Frame: at the time of collect (from 18m to 6 years of age) ]Measures of miRNA abundance in saliva
- Measures of adaptive function [ Time Frame: At time of enrollment (from 18m to 6 years of age) ]Vineland Adaptive Behavior Composite Score
- Measures of early intellectual development [ Time Frame: At time of enrollment (from 18m to 6 years of age) ]Mullen Scales of Early Learning
- Measure of autistic behavior [ Time Frame: At time of enrollment (from 18m to 6 years of age) ]Autism Diagnostic Observation Schedule (ADOS) Composite Score (Autism Group Only)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|