A Salivary miRNA Diagnostic Test for Autism

June 2, 2023 updated by: Frank A Middleton, State University of New York - Upstate Medical University

Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

998

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will compare salivary miRNA in children between the ages of 24 months and 48 months of age who are considered at risk for the development of autism spectrum disorder as identified by a score of 3 or greater on the MCHAT-R.

Description

Inclusion Criteria:

  • Age at enrollment: 24 months to 48 months (inclusive)
  • MCHAT-R score of 3 or greater
  • Parent/guardian must be fluent in spoken English (required to complete study specific questionnaires etc)

Exclusion Criteria:

  • confounding neurological (i.e. cerebral palsy, epilepsy), sensory (i.e. auditory or visual) impairments, and feeding tube dependence.
  • history of extreme pre-term birth (< 32 weeks gestation)
  • wards of the state
  • Autistic subjects with known syndromic autism (attributed to a known genetic mutation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MCHAT-R Positive
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary miRNA profile
Time Frame: at the time of collect (from 18m to 6 years of age)
Measures of miRNA abundance in saliva
at the time of collect (from 18m to 6 years of age)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measures of adaptive function
Time Frame: At time of enrollment (from 18m to 6 years of age)
Vineland Adaptive Behavior Composite Score
At time of enrollment (from 18m to 6 years of age)
Measures of early intellectual development
Time Frame: At time of enrollment (from 18m to 6 years of age)
Mullen Scales of Early Learning
At time of enrollment (from 18m to 6 years of age)
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)
At time of enrollment (from 18m to 6 years of age)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Collaborators

National Institute of Mental Health (NIMH)
University of Missouri-Columbia
Baylor College of Medicine
Milton S. Hershey Medical Center
Children's Hospital Medical Center, Cincinnati
Quadrant Biosciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimated)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 346301
  • R41MH111347 (U.S. NIH Grant/Contract)
  • R42MH111347 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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