Validation of a Salivary miRNA Diagnostic Test for ASD

February 6, 2023 updated by: Quadrant Biosciences Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6604

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Santa Ana, California, United States, 92705
        • Recruiting
        • University of California - Irvine
        • Contact:
          • Jean Gehricke, PhD
    • Georgia
      • Atlanta, Georgia, United States, 30319
        • Recruiting
        • Marcus Autism Center/Emory University
        • Contact:
          • Cheryl Klaiman, PhD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University
        • Contact:
          • Latha Soorya, PhD
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Medical School
        • Contact:
          • Jean Frazier, MD
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Lynn Cole, MS
      • Syracuse, New York, United States, 13210
        • Not yet recruiting
        • SUNY Upstate Medical University
        • Contact:
          • Henry Roane, PhD
      • Syracuse, New York, United States, 13210
        • Active, not recruiting
        • Quadrant Biosciences
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
          • Rebecca Shaffer, PsyD
      • Parma, Ohio, United States, 44130
        • Recruiting
        • MetroHealth Medical Center
        • Contact:
          • Melissa Armstrong-Brine, PhD
      • Westerville, Ohio, United States, 43081
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
          • Eric Butter, PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
          • Amanda Bennett, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Drexel University
        • Contact:
          • Diana Robins, PhD
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health-Upstate
        • Contact:
          • Karen Ratliff-Schaub, MD
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • Texas Children's Hospital/Baylor College of Medicine
        • Contact:
          • Robin Kochel, PhD
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:
          • Richard Stevenson, MD
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
          • Karen Bearss, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Autism Spectrum Disorder (ASD)
Other: Salivary Collection
Collection of saliva via swab for miRNA processing
Other: Adaptive Assessment
Includes Vineland Adaptive Behavior Scale or equivalent
Other: Medical and Demographic questionnaire
Survey that collects basic medical and demographic information
Other: Autism Assessment
Includes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent
Other: Intellectual Development Assessment
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
Non-ASD
Other: Salivary Collection
Collection of saliva via swab for miRNA processing
Other: Adaptive Assessment
Includes Vineland Adaptive Behavior Scale or equivalent
Other: Medical and Demographic questionnaire
Survey that collects basic medical and demographic information
Other: Autism Assessment
Includes Autism Diagnostic Observation Schedule (ADOS), Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS), Autism Diagnostic Interview - Revised (ADIR) or an equivalent
Other: Intellectual Development Assessment
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At the time of collection (from 18 months to 6 years 11 months of age)
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
At the time of the diagnostic evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Quadrant Biosciences Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital of Philadelphia
University of Pittsburgh
Emory University
Seattle Children's Hospital
State University of New York - Upstate Medical University
Nationwide Children's Hospital
University of California, Irvine
Children's Hospital Medical Center, Cincinnati
University of Virginia
University of Rochester
University of Massachusetts, Worcester
Children's Hospital Los Angeles
Holland Bloorview Kids Rehabilitation Hospital
Rush University
Drexel University
Prisma Health-Upstate
MetroHealth Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Levitskiy, MS, Quadrant Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20214744

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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