Validation of a Salivary miRNA Diagnostic Test for ASD

Recruiting

• Conditions: Developmental Delay; Autism Spectrum Disorder
• Interventions: Other: Salivary Collection; Other: Adaptive Assessment; Other: Medical and Demographic questionnaire; Other: Autism Assessment; Other: Intellectual Development Assessment

• Registration Number: NCT05418023
• Lead Sponsor: Quadrant Biosciences Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-06
• Study Start: 2022-03-16
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6604

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autism Spectrum Disorder (ASD)	Autism Assessment	-
Autism Spectrum Disorder (ASD)	Salivary Collection	-
Non-ASD	Salivary Collection	-
Non-ASD	Intellectual Development Assessment	-
Non-ASD	Adaptive Assessment	-
Autism Spectrum Disorder (ASD)	Medical and Demographic questionnaire	-
Autism Spectrum Disorder (ASD)	Intellectual Development Assessment	-
Non-ASD	Medical and Demographic questionnaire	-
Autism Spectrum Disorder (ASD)	Adaptive Assessment	-
Non-ASD	Autism Assessment	-

Primary Outcome Measures

Name	Time	Method
Salivary miRNA Profile	At the time of collection (from 18 months to 6 years 11 months of age)	Measures of miRNA abundance in saliva
DSM-5 Diagnosis	At the time of the diagnostic evaluation	Confirmation of participants meeting or not meeting the DSM-5 Criteria for a diagnosis of Autism Spectrum Disorder

Trial Locations

Locations (16)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States

Quadrant Biosciences; 🇺🇸 Syracuse, New York, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Marcus Autism Center/Emory University; 🇺🇸 Atlanta, Georgia, United States

RUSH University; 🇺🇸 Chicago, Illinois, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Nationwide Children's Hospital; 🇺🇸 Westerville, Ohio, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Texas Children's Hospital/Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

MetroHealth Medical Center; 🇺🇸 Parma, Ohio, United States

University of California - Irvine; 🇺🇸 Santa Ana, California, United States

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States

Prisma Health-Upstate; 🇺🇸 Greenville, South Carolina, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States