Status:
UNKNOWN
Validation of a Salivary miRNA Diagnostic Test for ASD
Lead Sponsor:
Quadrant Biosciences Inc.
Collaborating Sponsors:
University of California, Irvine
Holland Bloorview Kids Rehabilitation Hospital
Conditions:
Autism Spectrum Disorder
Developmental Delay
Eligibility:
All Genders
18-7 years
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. Partici...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
6604 Patients enrolled
Trial Details
Trial ID
NCT05418023
Start Date
March 16 2022
End Date
July 1 2023
Last Update
February 8 2023
Active Locations (16)
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1
University of California - Irvine
Santa Ana, California, United States, 92705
2
Marcus Autism Center/Emory University
Atlanta, Georgia, United States, 30319
3
RUSH University
Chicago, Illinois, United States, 60612
4
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655