Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
| Holland Bloorview Kids Rehabilitation Hospital | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| MetroHealth Medical Center |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autism Spectrum Disorder (ASD) |
| ||
| Non-ASD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salivary Collection | Other | Collection of saliva via swab for miRNA processing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Participants will be enrolled at pediatric offices, as well as specialist evaluation centers who are deemed at-risk for Autism Spectrum Disorder.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Brindle | Contact | 3153260760 | abrindle@quadrantbiosciences.com | |
| Arianna Montefusco | Contact | 3153260760 | arianna.montefusco@quadrantbiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| David Levitskiy, MS | Quadrant Biosciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Irvine | Recruiting | Santa Ana | California | 92705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27105825 | Background | 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. | |
| 30473705 | Background | 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. |
Not provided
Not provided
| OTHER |
| University of Rochester | OTHER |
| Nationwide Children's Hospital | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Pittsburgh | OTHER |
| University of Massachusetts, Worcester | OTHER |
| Children's Hospital Los Angeles | OTHER |
| Prisma Health-Upstate | OTHER |
| University of Virginia | OTHER |
| State University of New York - Upstate Medical University | OTHER |
| Rush University | OTHER |
| Seattle Children's Hospital | OTHER |
| Drexel University | OTHER |
| Emory University | OTHER |
Not provided
Not provided
Not provided
| Adaptive Assessment | Other | Includes Vineland Adaptive Behavior Scale or equivalent |
|
| Medical and Demographic questionnaire | Other | Survey that collects basic medical and demographic information |
|
| Autism Assessment | Other | 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 | Other | 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 |
|
| Marcus Autism Center/Emory University | Recruiting | Atlanta | Georgia | 30319 | United States |
|
| RUSH University | Not yet recruiting | Chicago | Illinois | 60612 | United States |
|
| University of Massachusetts Medical School | Recruiting | Worcester | Massachusetts | 01655 | United States |
|
| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
|
| Quadrant Biosciences | Active, not recruiting | Syracuse | New York | 13210 | United States |
| SUNY Upstate Medical University | Not yet recruiting | Syracuse | New York | 13210 | United States |
|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| MetroHealth Medical Center | Recruiting | Parma | Ohio | 44130 | United States |
|
| Nationwide Children's Hospital | Recruiting | Westerville | Ohio | 43081 | United States |
|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Drexel University | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Prisma Health-Upstate | Recruiting | Greenville | South Carolina | 29615 | United States |
|
| Texas Children's Hospital/Baylor College of Medicine | Recruiting | Houston | Texas | 77054 | United States |
|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
|
| 30926572 | Background | 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. |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided