Recruiting

Salivary miRNA

Sponsor:

Quadrant Biosciences Inc.

Code:

NCT05418023

Conditions

Autism Spectrum Disorder

Developmental Delay

Eligibility Criteria

Sex: All

Age: 1 - 7

Healthy Volunteers: Not accepted

Interventions

Salivary Collection

Adaptive Assessment

Medical and Demographic questionnaire

Autism Assessment

Intellectual Development Assessment

Study Details

Brief 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

Study ID

NCT05418023

Start date

Mar 16, 2022

Status verified date

Feb, 2023

Completion date

Jul, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 7

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 through 83 months old
  • The study will include children "at risk" for ASD as defined by meeting one or more of the following criteria:

  • flagged positive on a developmental screening tool (see below for assessment cut off scores)
  • the child has a biological sibling with ASD
  • Significant provider concern based on parent report noted in the child's medical chart at the time of the appointment.
  • Significant parental concern

Exclusion Criteria:

  • Feeding tube dependence
  • Active periodontal disease
  • Confounding neurological condition (i.e. cerebral palsy, epilepsy)
  • Sensory impairments (i.e. blindness or deafness)
  • Acute illnesses (i.e. upper respiratory infection)
  • Currently on antibiotics
  • Had taken antibiotics within the previous 30 days
  • Wards of the state

Study Design

Enrollment

6604 participants

Anticipated

Interventions and Outcome Measures

Arms

Autism Spectrum Disorder (ASD)

Non-ASD

Interventions

Salivary Collection

Collection of saliva via swab for miRNA processing

Adaptive Assessment

Includes Vineland Adaptive Behavior Scale or equivalent

Medical and Demographic questionnaire

Survey that collects basic medical and demographic information

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

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

Primary outcome measure

  • Salivary miRNA Profile [ Time Frame: At the time of collection (from 18 months to 6 years 11 months of age) ]
  • DSM-5 Diagnosis [ Time Frame: At the time of the diagnostic evaluation ]

Central Contacts and Locations

Central contacts

Andrew Brindle

3153260760abrindle@quadrantbiosciences.com

Arianna Montefusco

3153260760arianna.montefusco@quadrantbiosciences.com

Locations

University of California - Irvine

Recruiting

Santa Ana, California, United States, 92705

Marcus Autism Center/Emory University

Recruiting

Atlanta, Georgia, United States, 30319

University of Massachusetts Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

MetroHealth Medical Center

Recruiting

Parma, Ohio, United States, 44130

Nationwide Children's Hospital

Recruiting

Westerville, Ohio, United States, 43081

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Drexel University

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Prisma Health-Upstate

Recruiting

Greenville, South Carolina, United States, 29615

Texas Children's Hospital/Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77054

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Quadrant Biosciences Inc.

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Keywords

  • Autism Spectrum Disorder
  • ASD
  • Saliva
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Quadrant Biosciences Inc. on 2023-02-08.