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MAP Autism Prediction Study

NCT04672967 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-11-10

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

BioROSA MAP test

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

Sponsors & Collaborators

  • Melmed Center

    collaborator UNKNOWN

  • Vanderbilt University

    collaborator OTHER

  • BioROSA Technologies Inc

    lead INDUSTRY

Principal Investigators

  • Raun Melmed, MD · Melmed Center

Eligibility

Min Age
18 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2022-05-31
Completion
2022-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04672967 on ClinicalTrials.gov