Validation of a Salivary miRNA Diagnostic Test for ASD
Public ClinicalTrials.gov record NCT05418023. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05418023
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 6,604 participants
Conditions and interventions
Conditions
Interventions
- Salivary Collection Other
- Adaptive Assessment Other
- Medical and Demographic questionnaire Other
- Autism Assessment Other
- Intellectual Development Assessment Other
Other
Eligibility (public fields only)
- Age range
- 18 Months to 7 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2022
- Primary completion
- Jun 30, 2023
- Completion
- Jun 30, 2023
- Last update posted
- Feb 7, 2023
2022 – 2023
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California - Irvine | Santa Ana | California | 92705 | Recruiting |
| Marcus Autism Center/Emory University | Atlanta | Georgia | 30319 | Recruiting |
| RUSH University | Chicago | Illinois | 60612 | Not yet recruiting |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | Recruiting |
| University of Rochester | Rochester | New York | 14642 | Recruiting |
| Quadrant Biosciences | Syracuse | New York | 13210 | Active, not recruiting |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | Not yet recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Recruiting |
| MetroHealth Medical Center | Parma | Ohio | 44130 | Recruiting |
| Nationwide Children's Hospital | Westerville | Ohio | 43081 | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Drexel University | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Prisma Health-Upstate | Greenville | South Carolina | 29615 | Recruiting |
| Texas Children's Hospital/Baylor College of Medicine | Houston | Texas | 77054 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22903 | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05418023, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 7, 2023 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05418023 live on ClinicalTrials.gov.