MAP Autism Prediction Study

NCT04672967 | Unknown

• 1 other identifier: 1320036
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial tests the hypothesis that certain blood metabolite levels can be used to predict Autism Spectrum Disorder (ASD). The study cohort will consist of 200 participants between the ages 18 and 60 months who have been referred to a developmental pediatric center for clinical evaluation of ASD or other developmental delay. Two selected sites will enroll 75 participants each with another 50 typically developing participants. Participants will receive a physical exam (including a dysmorphology evaluation), ADOS, VABS, MSEL, DSM-5, and M-CHAT assessments, and receive a diagnosis. A fasting blood draw is required, consisting of 2 mL vacutainer tubes (max 4 mL). Sites must process blood according to sponsor requirements (outlined in the Sponsor's Laboratory Manual). Certain metabolite levels in the blood will be used for diagnostic screening test development.

Conditions

Autism Spectrum Disorder; Developmental Delay

Outcome Measures

Primary Outcomes (1)

• Autism Diagnostic Observation Scale (ADOS)

  The Autism Diagnostic Observation Schedule (ADOS) is considered a gold-standard instrument for diagnosing and assessing autism with good diagnostic sensitivity and specificity in young children (37). The ADOS consists of a series of structured and semi-structured tasks that involve social interaction between the examiner and the person under assessment. The examiner observes and identifies segments of the subject's behavior and assigns these to predetermined observational categories. Categorized observations are subsequently combined to produce quantitative scores for analysis and diagnostic classification of ASD. Children at or above predetermined cutoff lines are considered to be positive for ASD.

  1 day (At study entry (one time evaluation))

Secondary Outcomes (3)

• Vineland Adaptive Behavior Scale (VABS)

  1 day (At study entry (one time evaluation))

• Mullen Scales of Early Learning (MSEL)

  1 day (At study entry (one time evaluation))

• Modified Checklist for Autism in Toddlers (M-CHAT)

  1 day (At study entry (one time evaluation))

Study Arms (2)

Autism Spectrum Disorder

Children diagnosed with ASD between the ages of 18-60 months

Diagnostic Test: BioROSA MAP test

Non-ASD (developmental delay or typically developing)

Children diagnosed with non-ASD between the ages of 18-60 months

Diagnostic Test: BioROSA MAP test

Interventions

BioROSA MAP test DIAGNOSTIC_TEST

The BioROSA MAP test is a blood test that is being developed to predict ASD risk

Autism Spectrum Disorder; Non-ASD (developmental delay or typically developing)

Eligibility Criteria

• Age: 18 Months - 60 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Up to 250 participants, ages 18-60 months suspected of ASD or a developmental delay who are referred for evaluation at participating pediatric developmental centers.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• months of age
• Primary language is English (this is due to the evaluation instruments being used, which are in the English language).
• Suspected developmental concern and referral to the developmental center by child's physician
• Parental informed consent to participate in the study (based on the age range of the children in this study, assent is being waived)
• Willingness to comply with all study procedures
• Not currently enrolled in another clinical trial

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Previous diagnosis of ASD or DD
• Prematurity \< 34 weeks' gestation
• Has a sibling already enrolled in the trial
• Profound sensory deficits (e.g., hearing and vision deficits) that could interfere with the interpretation of study results
• Documented current or active seizures, as defined by a clinical seizure or abnormal EEG within the past six months
• Major genetic defect as determined by chromosomal microarray or other method of genetic detection
• Currently taking any high dose (greater than recommended daily allowance) dietary supplements
• Diagnosis or suspicion of recent viral/bacterial infection within 2 weeks of enrollment
• Diagnosis with congenital brain malformations, moderate to severe traumatic brain injury, congenital or acquired microcephaly, or infection of the central nervous system (e.g., meningitis, viral encephalitis)
• Fetal alcohol syndrome, Down syndrome, or another recognized syndrome
• Usage of acetaminophen (e.g., Tylenol) within the past 72 hours
• Fever (temperature \> 100 degrees Fahrenheit) within the past 72 hours
• Any other reason that the clinical investigator feels may place the participant at an unnecessary risk to participate

Sponsors & Collaborators

• BioROSA Technologies Inc: lead
• Melmed Center: collaborator
• Vanderbilt University: collaborator

Study Sites (1)

VUMC

Nashville, Tennessee, 37212, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting plasma samples will be collected to evaluate metabolites and other biomarkers which may be predictive of ASD

MeSH Terms

Conditions

Autism Spectrum Disorder; Learning Disabilities

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raun Melmed, MD

  Melmed Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig Ciuk

CONTACT

(480) 443-0050; craig.ciuk@melmedcenter.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: November 3, 2021
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)