Validation of a Salivary miRNA Diagnostic Test for ASD
1 other identifier
observational
6,604
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2022
CompletedStudy Start
First participant enrolled
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedFebruary 8, 2023
February 1, 2023
1.3 years
January 6, 2022
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Salivary miRNA Profile
Measures of miRNA abundance in saliva
At the time of collection (from 18 months to 6 years 11 months of age)
DSM-5 Diagnosis
Confirmation of participants meeting or not meeting the DSM-5 Criteria for a diagnosis of Autism Spectrum Disorder
At the time of the diagnostic evaluation
Study Arms (2)
Autism Spectrum Disorder (ASD)
Non-ASD
Interventions
Collection of saliva via swab for miRNA processing
Includes Vineland Adaptive Behavior Scale or equivalent
Survey that collects basic medical and demographic information
Includes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent
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
Eligibility Criteria
Participants will be enrolled at pediatric offices, as well as specialist evaluation centers who are deemed at-risk for Autism Spectrum Disorder.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Quadrant Biosciences Inc.lead
- University of California, Irvinecollaborator
- Holland Bloorview Kids Rehabilitation Hospitalcollaborator
- Children's Hospital of Philadelphiacollaborator
- MetroHealth Medical Centercollaborator
- University of Rochestercollaborator
- Nationwide Children's Hospitalcollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- University of Pittsburghcollaborator
- University of Massachusetts, Worcestercollaborator
- Children's Hospital Los Angelescollaborator
- Prisma Health-Upstatecollaborator
- University of Virginiacollaborator
- State University of New York - Upstate Medical Universitycollaborator
- Rush Universitycollaborator
- Seattle Children's Hospitalcollaborator
- Drexel Universitycollaborator
- Emory Universitycollaborator
Study Sites (16)
University of California - Irvine
Santa Ana, California, 92705, United States
Marcus Autism Center/Emory University
Atlanta, Georgia, 30319, United States
RUSH University
Chicago, Illinois, 60612, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
University of Rochester
Rochester, New York, 14642, United States
Quadrant Biosciences
Syracuse, New York, 13210, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MetroHealth Medical Center
Parma, Ohio, 44130, United States
Nationwide Children's Hospital
Westerville, Ohio, 43081, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Drexel University
Philadelphia, Pennsylvania, 19104, United States
Prisma Health-Upstate
Greenville, South Carolina, 29615, United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77054, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (3)
Hicks SD, Ignacio C, Gentile K, Middleton FA. Salivary miRNA profiles identify children with autism spectrum disorder, correlate with adaptive behavior, and implicate ASD candidate genes involved in neurodevelopment. BMC Pediatr. 2016 Apr 22;16:52. doi: 10.1186/s12887-016-0586-x.
PMID: 27105825BACKGROUNDHicks SD, Rajan AT, Wagner KE, Barns S, Carpenter RL, Middleton FA. Validation of a Salivary RNA Test for Childhood Autism Spectrum Disorder. Front Genet. 2018 Nov 9;9:534. doi: 10.3389/fgene.2018.00534. eCollection 2018.
PMID: 30473705BACKGROUNDHicks SD, Carpenter RL, Wagner KE, Pauley R, Barros M, Tierney-Aves C, Barns S, Greene CD, Middleton FA. Saliva MicroRNA Differentiates Children With Autism From Peers With Typical and Atypical Development. J Am Acad Child Adolesc Psychiatry. 2020 Feb;59(2):296-308. doi: 10.1016/j.jaac.2019.03.017. Epub 2019 Mar 27.
PMID: 30926572BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Levitskiy, MS
Quadrant Biosciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2022
First Posted
June 14, 2022
Study Start
March 16, 2022
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
February 8, 2023
Record last verified: 2023-02