Autism Spectrum DisorderNCT02832557
A Salivary miRNA Diagnostic Test for Autism
An observational study of Autism Spectrum Disorder and Developmental Delay, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of… Read more about this study
- Who is it for?
- Ages 24 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Developmental Delay
- What is being tested?
- Salivary collection, Vineland Adaptive Behavior Scale-III Assessment and Medical history questionaire
- How many people
- 998 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will compare salivary miRNA in children between the ages of 24 months and 48 months of age who are considered at risk for the development of autism spectrum disorder as identified by a score of 3 or greater on the MCHAT-R.
Who may be able to join
- Age at enrollment: 24 months to 48 months (inclusive)
- MCHAT-R score of 3 or greater
- Parent/guardian must be fluent in spoken English (required to complete study specific questionnaires etc)
Who cannot join
- confounding neurological (i.e. cerebral palsy, epilepsy), sensory (i.e. auditory or visual) impairments, and feeding tube dependence.
- history of extreme pre-term birth (< 32 weeks gestation)
- wards of the state
- Autistic subjects with known syndromic autism (attributed to a known genetic mutation)
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.
Read the detailed description
The central aim of this project is to validate a panel of expressed microRNA (miRNA) in the saliva of children identified at risk for developing ASD by the MCHAT-R. Further, this study aims to assess the value of the current panel as an adjunctive test that may increase specificity of MCHAT-R positive results, or affirm clinical diagnoses alongside the ADOS or other objective assessments.
The primary endpoints of this study are as follows:
- Evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary microtranscriptome panel for distinguishing children with ASD from their non-ASD peers.
- Assess stability of the salivary microtranscriptome diagnosis over time, and interrogate longitudinal microtranscriptome levels relative to neuropsychological measures.
Secondary endpoints are the identification of microtranscriptome features whose concentrations correlate with ASD endophenotypes.
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Being tested
- Salivary collection, Vineland Adaptive Behavior Scale-III Assessment, Medical history questionaire, Autism Diagnostic Observation Schedule -2nd edition (ADOS-2), Mullen Scales of Early Learning
- Keywords
- Autism, Asperger's Syndrome, microRNA, epigenetic, biomarker
- Medical subject headings
- Autism Spectrum Disorder, Learning Disabilities, Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary collectionOther
Collection of saliva via swab for miRNA processing
Vineland Adaptive Behavior Scale-III AssessmentOther
Medical history questionaireOther
Autism Diagnostic Observation Schedule -2nd edition (ADOS-2)Other
Mullen Scales of Early LearningOther
| Study group | Role | What they receive |
|---|---|---|
| MCHAT-R Positive | Children identified at risk for the development of autism spectrum disorder (ASD) by scoring a 3 or higher on the MCHAT-R. Participants should not have a history of extreme pre-term birth or underlying neurological disorders such as seizures or cerebral palsy. Receives: Other: Salivary collection; Other: Vineland Adaptive Behavior Scale-III Assessment; Other: Medical history questionaire; Other: Autism Diagnostic Observation Schedule -2nd edition (ADOS-2); Other: Mullen Scales of Early Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary miRNA profile
Measures of miRNA abundance in saliva
Measured: at the time of collect (from 18m to 6 years of age)
Secondary outcomes (3)
Measures of adaptive function
Vineland Adaptive Behavior Composite Score
Measured: At time of enrollment (from 18m to 6 years of age)
Measures of early intellectual development
Mullen Scales of Early Learning
Measured: At time of enrollment (from 18m to 6 years of age)
Measure of autistic behavior
Autism Diagnostic Observation Schedule (ADOS) Composite Score (Autism Group Only)
Measured: At time of enrollment (from 18m to 6 years of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start1 Nov 2015
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 998 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Quadrant Biosciences Inc., Milton S. Hershey Medical Center, University of Missouri-Columbia, Children's Hospital Medical Center, Cincinnati, Baylor College of Medicine
- Responsible party
- Principal investigator, Frank A Middleton, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832557
- Sponsor's protocol ID
- 346301
- Other IDs
- R41MH111347, R42MH111347
- Status last verified
- Jun 2023
- First submitted
- 12 Jul 2016
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27105825Hicks 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.
PubMed 30473705Hicks 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.
PubMed 30926572
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02832557
- Acronym / sponsor ID
- 346301
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Keywords
- Autism, Asperger's Syndrome, microRNA, epigenetic, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Quadrant Biosciences Inc., Milton S. Hershey Medical Center, University of Missouri-Columbia, Children's Hospital Medical Center, Cincinnati, Baylor College of Medicine
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.
Detailed description
The central aim of this project is to validate a panel of expressed microRNA (miRNA) in the saliva of children identified at risk for developing ASD by the MCHAT-R. Further, this study aims to assess the value of the current panel as an adjunctive test that may increase specificity of MCHAT-R positive results, or affirm clinical diagnoses alongside the ADOS or other objective assessments.
The primary endpoints of this study are as follows:
- Evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary microtranscriptome panel for distinguishing children with ASD from their non-ASD peers.
- Assess stability of the salivary microtranscriptome diagnosis over time, and interrogate longitudinal microtranscriptome levels relative to neuropsychological measures.
Secondary endpoints are the identification of microtranscriptome features whose concentrations correlate with ASD endophenotypes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCHAT-R Positive | – | Other: Salivary collection, Other: Vineland Adaptive Behavior Scale-III Assessment, Other: Medical history questionaire, Other: Autism Diagnostic Observation Schedule -2nd edition (ADOS-2), Other: Mullen Scales of Early LearningChildren identified at risk for the development of autism spectrum disorder (ASD) by scoring a 3 or higher on the MCHAT-R. Participants should not have a history of extreme pre-term birth or underlying neurological disorders such as seizures or cerebral palsy. |
Who may qualify
- Ages
- 24 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will compare salivary miRNA in children between the ages of 24 months and 48 months of age who are considered at risk for the development of autism spectrum disorder as identified by a score of 3 or greater on the MCHAT-R.
Key inclusion criteria (3 listed)
- Age at enrollment: 24 months to 48 months (inclusive)
- MCHAT-R score of 3 or greater
- Parent/guardian must be fluent in spoken English (required to complete study specific questionnaires etc)
Key exclusion criteria (4 listed)
- confounding neurological (i.e. cerebral palsy, epilepsy), sensory (i.e. auditory or visual) impairments, and feeding tube dependence.
- history of extreme pre-term birth (< 32 weeks gestation)
- wards of the state
- Autistic subjects with known syndromic autism (attributed to a known genetic mutation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary collectionCollection of saliva via swab for miRNA processing | Other | MCHAT-R Positive |
| Vineland Adaptive Behavior Scale-III Assessment | Other | MCHAT-R Positive |
| Medical history questionaire | Other | MCHAT-R Positive |
| Autism Diagnostic Observation Schedule -2nd edition (ADOS-2) | Other | MCHAT-R Positive |
| Mullen Scales of Early Learning | Other | MCHAT-R Positive |
Primary outcome
Salivary miRNA profile
Time frame: at the time of collect (from 18m to 6 years of age)
Measures of miRNA abundance in saliva
3 secondary outcomes
Measures of adaptive function
Time frame: At time of enrollment (from 18m to 6 years of age)
Measures of early intellectual development
Time frame: At time of enrollment (from 18m to 6 years of age)
Measure of autistic behavior
Time frame: At time of enrollment (from 18m to 6 years of age)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Background: PubMed 27105825Hicks 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.
- Background: PubMed 30473705Hicks 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.
- Derived from this study: PubMed 30926572Hicks 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Developmental Delay, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary miRNA profile (time frame: at the time of collect (from 18m to 6 years of age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02832557, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.