RECRUITING

Validation of a Salivary miRNA Diagnostic Test for ASD

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Conditions

Autism Spectrum DisorderDevelopmental DelayASDSalivaBiomarkers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder

Quick Facts

Study Start:2022-03-16
Study Completion:2023-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05418023

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.

Ages Eligible for Study:18 Months to 7 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 18 through 83 months old
  2. * The study will include children "at risk" for ASD as defined by meeting one or more of the following criteria:
  3. * flagged positive on a developmental screening tool (see below for assessment cut off scores)
  4. * the child has a biological sibling with ASD
  5. * Significant provider concern based on parent report noted in the child's medical chart at the time of the appointment.
  6. * Significant parental concern
  1. * Feeding tube dependence
  2. * Active periodontal disease
  3. * Confounding neurological condition (i.e. cerebral palsy, epilepsy)
  4. * Sensory impairments (i.e. blindness or deafness)
  5. * Acute illnesses (i.e. upper respiratory infection)
  6. * Currently on antibiotics
  7. * Had taken antibiotics within the previous 30 days
  8. * Wards of the state

Contacts and Locations

Study Contact

Andrew Brindle
CONTACT
3153260760
abrindle@quadrantbiosciences.com
Arianna Montefusco
CONTACT
3153260760
arianna.montefusco@quadrantbiosciences.com

Principal Investigator

David Levitskiy, MS
PRINCIPAL_INVESTIGATOR
Quadrant Biosciences

Study Locations (Sites)

University of California - Irvine
Santa Ana, California, 92705
United States
Marcus Autism Center/Emory University
Atlanta, Georgia, 30319
United States
RUSH University
Chicago, Illinois, 60612
United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
United States
University of Rochester
Rochester, New York, 14642
United States
Quadrant Biosciences
Syracuse, New York, 13210
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
MetroHealth Medical Center
Parma, Ohio, 44130
United States
Nationwide Children's Hospital
Westerville, Ohio, 43081
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Drexel University
Philadelphia, Pennsylvania, 19104
United States
Prisma Health-Upstate
Greenville, South Carolina, 29615
United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77054
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Quadrant Biosciences Inc.

  • David Levitskiy, MS, PRINCIPAL_INVESTIGATOR, Quadrant Biosciences

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 Registration Dates

Study Start Date2022-03-16
Study Completion Date2023-07

Study Record Updates

Study Start Date2022-03-16
Study Completion Date2023-07

Terms related to this study

Keywords Provided by Researchers

  • Autism Spectrum Disorder
  • ASD
  • Saliva
  • Biomarkers

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Developmental Delay