CompletedNot Applicable

A Salivary miRNA Diagnostic Test for Autism

United States998 participantsStarted 2015-11-01

Plain-language 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.

Who can participate

Age range24 Months – 48 Months

SexALL

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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)

What they're measuring

Salivary miRNA profile

Timeframe: at the time of collect (from 18m to 6 years of age)

Trial details

NCT IDNCT02832557

SponsorState University of New York - Upstate Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-08-31

View on ClinicalTrials.gov More Autism Spectrum Disorder trials