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Validation of a Salivary miRNA Diagnostic Test for ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05418023
Recruitment Status : Recruiting
First Posted : June 14, 2022
Last Update Posted : June 14, 2022
Sponsor:
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
Information provided by (Responsible Party):
Quadrant Biosciences Inc.

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Developmental Delay Other: Salivary Collection Other: Adaptive Assessment Other: Medical and Demographic questionnaire Other: Autism Assessment Other: Intellectual Development Assessment

Study Design
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Study Type : Observational
Estimated Enrollment : 6604 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
Actual Study Start Date : March 16, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05418023


Contacts
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Contact: Andrew Brindle 3153260760 abrindle@quadrantbiosciences.com
Contact: Arianna Montefusco 3153260760 arianna.montefusco@quadrantbiosciences.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Quadrant Biosciences Inc.
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
Investigators
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Principal Investigator: David Levitskiy, MS Quadrant Biosciences
More Information
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Publications:

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Responsible Party: Quadrant Biosciences Inc.
ClinicalTrials.gov Identifier: NCT05418023    
Other Study ID Numbers: 20214744
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quadrant Biosciences Inc.:
Autism Spectrum Disorder
ASD
Saliva
Biomarkers
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders