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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 : August 27, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Quadrant Biosciences, Inc.
Milton S. Hershey Medical Center
University of Missouri-Columbia
Children's Hospital Medical Center, Cincinnati
Baylor College of Medicine
Information provided by (Responsible Party):
Frank A Middleton, State University of New York - Upstate Medical University

Brief 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.

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

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.

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Salivary miRNA profile [ Time Frame: at the time of collect (from 18m to 6 years of age) ]
    Measures of miRNA abundance in saliva


Secondary Outcome Measures :
  1. Measures of adaptive function [ Time Frame: At time of enrollment (from 18m to 6 years of age) ]
    Vineland Adaptive Behavior Composite Score

  2. Measures of early intellectual development [ Time Frame: At time of enrollment (from 18m to 6 years of age) ]
    Mullen Scales of Early Learning

  3. 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
Salivary RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Frank Middleton, PhD 315-464-7729 middletf@upstate.edu

Locations
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United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Frank A Middleton, PhD    315-464-7729    middletf@upstate.edu   
Principal Investigator: Frank Middleton A Middleton, PhD         
Sponsors and Collaborators
State University of New York - Upstate Medical University
National Institute of Mental Health (NIMH)
Quadrant Biosciences, Inc.
Milton S. Hershey Medical Center
University of Missouri-Columbia
Children's Hospital Medical Center, Cincinnati
Baylor College of Medicine
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Frank A Middleton, Principal Investigator/Associate Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT02832557    
Other Study ID Numbers: 346301
R41MH111347 ( U.S. NIH Grant/Contract )
R42MH111347 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Frank A Middleton, State University of New York - Upstate Medical University:
Autism
Asperger's Syndrome
microRNA
epigenetic
biomarker
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders