Validation of a Salivary miRNA Diagnostic Test for ASD

Description

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 Overview

Study Details

Study overview

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.

Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder

Validation of a Salivary miRNA Diagnostic Test for ASD

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

Santa Ana

University of California - Irvine, Santa Ana, California, United States, 92705

Atlanta

Marcus Autism Center/Emory University, Atlanta, Georgia, United States, 30319

Chicago

RUSH University, Chicago, Illinois, United States, 60612

Worcester

University of Massachusetts Medical School, Worcester, Massachusetts, United States, 01655

Rochester

University of Rochester, Rochester, New York, United States, 14642

Syracuse

Quadrant Biosciences, Syracuse, New York, United States, 13210

Syracuse

SUNY Upstate Medical University, Syracuse, New York, United States, 13210

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Parma

MetroHealth Medical Center, Parma, Ohio, United States, 44130

Westerville

Nationwide Children's Hospital, Westerville, Ohio, United States, 43081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Months to 7 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Quadrant Biosciences Inc.,

David Levitskiy, MS, PRINCIPAL_INVESTIGATOR, Quadrant Biosciences

Study Record Dates

2023-07