Validation of a Salivary miRNA Diagnostic Test for ASD

Autism Spectrum Disorder Clinical Trial

Official title:

Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418023
• Other study ID #: 20214744
• Status: Recruiting
• Start date: March 16, 2022
• Est. completion date: July 2023

Study information

• Verified date: February 2023
• Source: Quadrant Biosciences Inc.
• Contact: Andrew Brindle
• Phone: 3153260760
• Email: abrindle[@]quadrantbiosciences.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6604
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Delay

Intervention

Other:
• Salivary Collection
Collection of saliva via swab for miRNA processing
• Adaptive Assessment
Includes Vineland Adaptive Behavior Scale or equivalent
• Medical and Demographic questionnaire
Survey that collects basic medical and demographic information
• Autism Assessment
Includes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent
• Intellectual Development Assessment
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

Locations

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

Sponsors (18)

Lead Sponsor

Collaborator

Quadrant Biosciences Inc.

Children's Hospital Los Angeles, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Drexel University, Emory University, Holland Bloorview Kids Rehabilitation Hospital, MetroHealth Medical Center, Nationwide Children's Hospital, Prisma Health-Upstate, Rush University, Seattle Children's Hospital, State University of New York - Upstate Medical University, University of California, Irvine, University of Massachusetts, Worcester, University of Pittsburgh, University of Rochester, University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hicks 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. — View Citation

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. — View Citation

Hicks 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary miRNA Profile	Measures of miRNA abundance in saliva	At the time of collection (from 18 months to 6 years 11 months of age)
Primary	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