Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT02832557
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2016-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Salivary miRNA Diagnostic Test for Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D020817', 'term': 'Asperger Syndrome'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Salivary RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 998}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2016-07-12', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary miRNA profile', 'timeFrame': 'at the time of collect (from 18m to 6 years of age)', 'description': 'Measures of miRNA abundance in saliva'}], 'secondaryOutcomes': [{'measure': 'Measures of adaptive function', 'timeFrame': 'At time of enrollment (from 18m to 6 years of age)', 'description': 'Vineland Adaptive Behavior Composite Score'}, {'measure': 'Measures of early intellectual development', 'timeFrame': 'At time of enrollment (from 18m to 6 years of age)', 'description': 'Mullen Scales of Early Learning'}, {'measure': 'Measure of autistic behavior', 'timeFrame': 'At time of enrollment (from 18m to 6 years of age)', 'description': 'Autism Diagnostic Observation Schedule (ADOS) Composite Score (Autism Group Only)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autism', "Asperger's Syndrome", 'microRNA', 'epigenetic', 'biomarker'], 'conditions': ['Autism Spectrum Disorder', 'Developmental Delay']}, 'referencesModule': {'references': [{'pmid': '27105825', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30473705', 'type': 'BACKGROUND', 'citation': 'Hicks 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.'}, {'pmid': '30926572', 'type': 'DERIVED', 'citation': 'Hicks 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe primary endpoints of this study are as follows:\n\n1. Evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary microtranscriptome panel for distinguishing children with ASD from their non-ASD peers.\n2. Assess stability of the salivary microtranscriptome diagnosis over time, and interrogate longitudinal microtranscriptome levels relative to neuropsychological measures.\n\nSecondary endpoints are the identification of microtranscriptome features whose concentrations correlate with ASD endophenotypes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '24 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at enrollment: 24 months to 48 months (inclusive)\n* MCHAT-R score of 3 or greater\n* Parent/guardian must be fluent in spoken English (required to complete study specific questionnaires etc)\n\nExclusion Criteria:\n\n* confounding neurological (i.e. cerebral palsy, epilepsy), sensory (i.e. auditory or visual) impairments, and feeding tube dependence.\n* history of extreme pre-term birth (\\< 32 weeks gestation)\n* wards of the state\n* Autistic subjects with known syndromic autism (attributed to a known genetic mutation)'}, 'identificationModule': {'nctId': 'NCT02832557', 'briefTitle': 'A Salivary miRNA Diagnostic Test for Autism', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Upstate Medical University'}, 'officialTitle': 'Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': '346301'}, 'secondaryIdInfos': [{'id': 'R41MH111347', 'link': 'https://reporter.nih.gov/quickSearch/R41MH111347', 'type': 'NIH'}, {'id': 'R42MH111347', 'link': 'https://reporter.nih.gov/quickSearch/R42MH111347', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'MCHAT-R Positive', 'description': '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.', 'interventionNames': ['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']}], 'interventions': [{'name': 'Salivary collection', 'type': 'OTHER', 'description': 'Collection of saliva via swab for miRNA processing', 'armGroupLabels': ['MCHAT-R Positive']}, {'name': 'Vineland Adaptive Behavior Scale-III Assessment', 'type': 'OTHER', 'armGroupLabels': ['MCHAT-R Positive']}, {'name': 'Medical history questionaire', 'type': 'OTHER', 'armGroupLabels': ['MCHAT-R Positive']}, {'name': 'Autism Diagnostic Observation Schedule -2nd edition (ADOS-2)', 'type': 'OTHER', 'armGroupLabels': ['MCHAT-R Positive']}, {'name': 'Mullen Scales of Early Learning', 'type': 'OTHER', 'armGroupLabels': ['MCHAT-R Positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Quadrant Biosciences Inc.', 'class': 'INDUSTRY'}, {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator/Associate Professor', 'investigatorFullName': 'Frank A Middleton', 'investigatorAffiliation': 'State University of New York - Upstate Medical University'}}}}