Clinical trial NCT05418023: Validation of a Salivary miRNA Diagnostic Test for ASD
Official title: Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Developmental Delay
Keywords: Autism Spectrum Disorder
ASD
Saliva
Biomarkers
Lead sponsor: Quadrant Biosciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, Irvine
name: Holland Bloorview Kids Rehabilitation Hospital
name: Children's Hospital of Philadelphia
name: MetroHealth Medical Center
name: University of Rochester
name: Nationwide Children's Hospital
name: Children's Hospital Medical Center, Cincinnati
name: University of Pittsburgh
name: University of Massachusetts, Worcester
name: Children's Hospital Los Angeles
name: Prisma Health-Upstate
name: University of Virginia
name: State University of New York - Upstate Medical University
name: Rush University
name: Seattle Children's Hospital
name: Drexel University
name: Emory University
First posted: 2022-06-14
Enrollment: 6604
Sex: ALL
Minimum age (years): 18
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled at pediatric offices, as well as specialist evaluation centers who are deemed at-risk for Autism Spectrum Disorder.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Salivary miRNA Profile
timeFrame: At the time of collection (from 18 months to 6 years 11 months of age)
measure: DSM-5 Diagnosis
timeFrame: At the time of the diagnostic evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: University of California - Irvine
state: California
city: Atlanta
country: United States
facility: Marcus Autism Center/Emory University
state: Georgia
city: Chicago
country: United States
facility: RUSH University
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Syracuse
country: United States
facility: Quadrant Biosciences
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Parma
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Westerville
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health-Upstate
state: South Carolina
city: Houston
country: United States
facility: Texas Children's Hospital/Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Quadrant Biosciences
name: David Levitskiy, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.