Validation of a Salivary miRNA Diagnostic Test for ASD

Status unconfirmed

Conditions studied: Autism Spectrum Disorder, Developmental Delay

In brief

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.

Key facts

Study ID

NCT05418023

Run by

Quadrant Biosciences Inc.

People needed

6604

Starts

2022-03-16

Expected to finish

2023-07-01

Last updated by the study team

2023-02-08

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• Marcus Autism Center/Emory University — Atlanta, Georgia, United States (enrolling)
• Texas Children's Hospital/Baylor College of Medicine — Houston, Texas, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• University of California - Irvine — Santa Ana, California, United States (enrolling)
• University of Massachusetts Medical School — Worcester, Massachusetts, United States (enrolling)
• University of Rochester — Rochester, New York, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• MetroHealth Medical Center — Parma, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Westerville, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Drexel University — Philadelphia, Pennsylvania, United States (enrolling)
• Prisma Health-Upstate — Greenville, South Carolina, United States (enrolling)
• RUSH University — Chicago, Illinois, United States
• Quadrant Biosciences — Syracuse, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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