Autism Spectrum DisorderNCT05418023
Validation of a Salivary miRNA Diagnostic Test for ASD
An observational study of Autism Spectrum Disorder and Developmental Delay, run by Quadrant Biosciences Inc. at 16 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 months to 7 years
- Conditions the study is for
- Autism Spectrum Disorder, Developmental Delay
- What is being tested?
- Salivary Collection, Adaptive Assessment and Medical and Demographic questionnaire
- How many people
- 6,604 participants
- Where
- 16 sitesUnited States
- Study dates
- 16 Mar 2022to Jul 2023
- 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 18 months to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be enrolled at pediatric offices, as well as specialist evaluation centers who are deemed at-risk for Autism Spectrum Disorder.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites, 15 recruiting
- Recruiting
Marcus Autism Center/Emory University
Atlanta, Georgia, 30319
Cheryl Klaiman, PhD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Richard Stevenson, MD
- Not yet recruiting
RUSH University
Chicago, Illinois, 60612
Latha Soorya, PhD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rebecca Shaffer, PsyD
- Recruiting
Prisma Health-Upstate
Greenville, South Carolina, 29615
Karen Ratliff-Schaub, MD
- Recruiting
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77054
Robin Kochel, PhD
- Recruiting
MetroHealth Medical Center
Parma, Ohio, 44130
Melissa Armstrong-Brine, PhD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Amanda Bennett, MD
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Diana Robins, PhD
- Recruiting
University of Rochester
Rochester, New York, 14642
Lynn Cole, MS
- Recruiting
University of California - Irvine
Santa Ana, California, 92705
Jean Gehricke, PhD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Karen Bearss, PhD
- Active, not recruiting
Quadrant Biosciences
Syracuse, New York, 13210
- Not yet recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
Henry Roane, PhD
- Recruiting
Nationwide Children's Hospital
Westerville, Ohio, 43081
Eric Butter, PhD
- Recruiting
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Jean Frazier, MD
About this study
Official title: Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
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.
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Being tested
- Salivary Collection, Adaptive Assessment, Medical and Demographic questionnaire, Autism Assessment, Intellectual Development Assessment
- Keywords
- Autism Spectrum Disorder, ASD, Saliva, Biomarkers
- Medical subject headings
- Autism Spectrum Disorder, Learning Disabilities
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
Adaptive AssessmentOther
Includes Vineland Adaptive Behavior Scale or equivalent
Medical and Demographic questionnaireOther
Survey that collects basic medical and demographic information
Autism AssessmentOther
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 AssessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder (ASD) | Not described Receives: Other: Salivary Collection; Other: Adaptive Assessment; Other: Medical and Demographic questionnaire; Other: Autism Assessment; Other: Intellectual Development Assessment | |
| Non-ASD | Not described Receives: Other: Salivary Collection; Other: Adaptive Assessment; Other: Medical and Demographic questionnaire; Other: Autism Assessment; Other: Intellectual Development Assessment |
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 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
Measured: At the time of the diagnostic evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start16 Mar 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
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
- 6,604 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quadrant Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine, Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital of Philadelphia, MetroHealth Medical Center, University of Rochester, Nationwide Children's Hospital, Children's Hospital Medical Center, Cincinnati, University of Pittsburgh, University of Massachusetts, Worcester, Children's Hospital Los Angeles, Prisma Health-Upstate, University of Virginia, State University of New York - Upstate Medical University, Rush University, Seattle Children's Hospital, Drexel University, Emory University
- Responsible party
- Sponsor
- Investigators
- David Levitskiy, MS, Principal investigator, Quadrant Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418023
- Sponsor's protocol ID
- 20214744
- Status last verified
- Feb 2023
- First submitted
- 6 Jan 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 8 Feb 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
- NCT05418023
- Acronym / sponsor ID
- 20214744
- Conditions
- Autism Spectrum Disorder, Developmental Delay
- Keywords
- Autism Spectrum Disorder, ASD, Saliva, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,604 participants (estimated)
- Lead sponsor
- Quadrant Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine, Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital of Philadelphia, MetroHealth Medical Center, University of Rochester, Nationwide Children's Hospital, Children's Hospital Medical Center, Cincinnati, University of Pittsburgh, University of Massachusetts, Worcester, Children's Hospital Los Angeles, Prisma Health-Upstate, University of Virginia, State University of New York - Upstate Medical University, Rush University, Seattle Children's Hospital, Drexel University, Emory University
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 14 Jun 2022 (actual)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder (ASD) | – | Other: Salivary Collection, Other: Adaptive Assessment, Other: Medical and Demographic questionnaire, Other: Autism Assessment, Other: Intellectual Development Assessment |
| Non-ASD | – | Other: Salivary Collection, Other: Adaptive Assessment, Other: Medical and Demographic questionnaire, Other: Autism Assessment, Other: Intellectual Development Assessment |
Who may qualify
- Ages
- 18 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be enrolled at pediatric offices, as well as specialist evaluation centers who are deemed at-risk for Autism Spectrum Disorder.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (8 listed)
- 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)
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 | Autism Spectrum Disorder (ASD), Non-ASD |
| Adaptive AssessmentIncludes Vineland Adaptive Behavior Scale or equivalent | Other | Autism Spectrum Disorder (ASD), Non-ASD |
| Medical and Demographic questionnaireSurvey that collects basic medical and demographic information | Other | Autism Spectrum Disorder (ASD), Non-ASD |
| Autism AssessmentIncludes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent | Other | Autism Spectrum Disorder (ASD), Non-ASD |
| Intellectual Development AssessmentIncludes 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 | Other | Autism Spectrum Disorder (ASD), Non-ASD |
Primary outcome
Salivary miRNA Profile
Time frame: At the time of collection (from 18 months to 6 years 11 months of age)
Measures of miRNA abundance in saliva
DSM-5 Diagnosis
Time frame: At the time of the diagnostic evaluation
Confirmation of participants meeting or not meeting the DSM-5 Criteria for a diagnosis of Autism Spectrum Disorder
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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.
- Background: 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.
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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.
David Levitskiy, MS principal investigator
Quadrant Biosciences
16 sites 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 Quadrant Biosciences Inc. at 16 sites 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Brindle (3153260760, abrindle@quadrantbiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary miRNA Profile (time frame: At the time of collection (from 18 months to 6 years 11 months of age)). The study lists 2 primary outcomes in all. 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 NCT05418023, 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 8 Feb 2023.