NCT05418023

Validation of a Salivary miRNA Diagnostic Test for ASD

Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 6,604 (estimated)
• Sponsor: Quadrant Biosciences Inc. · Industry
• Sex: All
• Age: 18 Months – 7 Years
• Healthy volunteers: Not accepted

Summary

This study involves sample collection to identify biomarkers relating to Autism Spectrum Disorder(ASD) in the saliva of children who are between the ages of 18 months to 6 years and 11 months. Participants will at each timepoint have a non-invasive saliva swab collected and complete a brief demographic and medical history questionnaire as well. Children in the pediatric/provider setting who will receive a referral for an ASD diagnosis because they were determined to have a suspicion of developing ASD will be enrolled in the study. Children will also be enrolled in the specialist evaluation setting where they will receive a DSM-5 diagnosis. A subset of both enrollment cohorts will also be followed up with at a third time point in which their diagnosis will be confirmed, and information about any ongoing treatment will be gathered.

Conditions

• Autism Spectrum Disorder
• Developmental Delay

Interventions

Type	Name	Description
OTHER	Salivary Collection	Collection of saliva via swab for miRNA processing
OTHER	Adaptive Assessment	Includes Vineland Adaptive Behavior Scale or equivalent
OTHER	Medical and Demographic questionnaire	Survey that collects basic medical and demographic information
OTHER	Autism Assessment	Includes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent
OTHER	Intellectual Development Assessment	Includes Mullens Scales of Early Learning, Stanford Binet Intelligence Scales, Wechsler Preschool and Primary Scale of Intelligence (WPPSI), Bayley Scales of Infant Development or an equivalent

Timeline

• Start date: 2022-03-16
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2022-06-14
• Last updated: 2023-02-08

Locations

16 sites across 1 country: United States