A Salivary miRNA Diagnostic Test for Autism

NCT02832557 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 998

Last updated 2023-06-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Quadrant Biosciences Inc.

    collaborator INDUSTRY
  • Milton S. Hershey Medical Center

    collaborator OTHER
  • University of Missouri-Columbia

    collaborator OTHER
  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER
  • Baylor College of Medicine

    collaborator OTHER
  • State University of New York - Upstate Medical University

    lead OTHER

Eligibility

Min Age
24 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02832557 on ClinicalTrials.gov