Recruiting

Autism Prediction

Sponsor:

BioROSA Technologies Inc

Code:

NCT04672967

Conditions

Autism Spectrum Disorder

Developmental Delay

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

Interventions

BioROSA MAP test

Study Details

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

Study ID

NCT04672967

Start date

Nov 3, 2021

Status verified date

Nov, 2021

Completion date

Oct, 2022

Anticipated

Primary completion date

May, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. 18-60 months of age
2. Primary language is English (this is due to the evaluation instruments being used, which are in the English language).
3. Suspected developmental concern and referral to the developmental center by child's physician
4. Parental informed consent to participate in the study (based on the age range of the children in this study, assent is being waived)
5. Willingness to comply with all study procedures
6. Not currently enrolled in another clinical trial

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Previous diagnosis of ASD or DD
2. Prematurity < 34 weeks' gestation
3. Has a sibling already enrolled in the trial
4. Profound sensory deficits (e.g., hearing and vision deficits) that could interfere with the interpretation of study results
5. Documented current or active seizures, as defined by a clinical seizure or abnormal EEG within the past six months
6. Major genetic defect as determined by chromosomal microarray or other method of genetic detection
7. Currently taking any high dose (greater than recommended daily allowance) dietary supplements
8. Diagnosis or suspicion of recent viral/bacterial infection within 2 weeks of enrollment
9. 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)
10. Fetal alcohol syndrome, Down syndrome, or another recognized syndrome
11. Usage of acetaminophen (e.g., Tylenol) within the past 72 hours
12. Fever (temperature > 100 degrees Fahrenheit) within the past 72 hours
13. Any other reason that the clinical investigator feels may place the participant at an unnecessary risk to participate

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Autism Spectrum Disorder

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

Non-ASD (developmental delay or typically developing)

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

Interventions

BioROSA MAP test

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

Primary outcome measure

  • Autism Diagnostic Observation Scale (ADOS) [ Time Frame: 1 day (At study entry (one time evaluation)) ]

Central Contacts and Locations

Locations

VUMC

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Principal Investigator:

Allyson Witters-Cundiff, MD

More Information

Sponsor

BioROSA Technologies Inc

Last update posted

Nov 10, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BioROSA Technologies Inc on 2021-11-10.