MAP Autism Prediction Study

NCT ID: NCT04672967

Last Updated: 2021-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2022-10-31

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.

Detailed Description

The primary objective is to conduct a double-blind, proof-of-concept, two-site, prospective study of 200 children aged 18-60 months that have been referred for an ASD evaluation by a physician to assess the feasibility of a blood test that measures a set of blood plasma metabolites and the classification algorithm developed thereof to predict the risk of ASD.

The secondary objective is to collect additional information for sub-classification of participant cohorts including Vineland Adaptive Behavior Scale (VABS) and Mullen Scale of Early Learning (MSEL) as well as any comorbidities that may correlate with blood test scores.

Conditions

Autism Spectrum Disorder; Developmental Delay

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Autism Spectrum Disorder

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

BioROSA MAP test

Intervention Type: DIAGNOSTIC_TEST

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

Non-ASD (developmental delay or typically developing)

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

BioROSA MAP test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

BioROSA MAP test

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melmed Center

UNKNOWN

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

BioROSA Technologies Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raun Melmed, MD

Role: PRINCIPAL_INVESTIGATOR

Melmed Center

Locations

VUMC

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Craig Ciuk

Role: CONTACT

Phone: (480) 443-0050

Email: craig.ciuk@melmedcenter.com

Facility Contacts

Sarah Marler

Role: primary

Caroline Roof

Role: backup

Other Identifiers

1320036

Identifier Type: -

Identifier Source: org_study_id