Children's Autism Metabolome Project

Status unconfirmed

Conditions studied: Autism Spectrum Disorder, Developmental Disorder

In brief

Development and Clinical Evaluation of the Stemina Metabolic Biomarker-Based Test to Diagnose Autism Spectrum Disorder in Early Childhood.

Key facts

Study ID

NCT02548442

Run by

Stemina Biomarker Discovery, Inc.

People needed

1102

Starts

2015-08-01

Expected to finish

2023-08-01

Last updated by the study team

2020-06-29

Who can join

Age: 2 and older, up to 4. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age of greater or equal to 18 months and less than or equal to 48 months
• Fulfills the definition of an autism spectrum disorder, developmentally delayed, or typically developing child in the age range 18-48 months, as determined by a clinician or certified practitioner of the appropriate tests and who is knowledgeable in the field; and
• Has parental (or other legal guardian ) informed consent to participate.

You may not qualify if…

• Diagnosis with a chronic condition that could interfere with a diagnosis of ASD or DD, (e.g.: a known history of Fragile X, Rett syndrome, Down syndrome, tuberous sclerosis, trisomy 21, inborn errors of metabolism or other genetic disorder that includes some symptoms of autism)
• Fetal alcohol syndrome, or other serious neurological disorder
• Other serious metabolic disorder, psychiatric disorder, or medical condition involving the liver, kidney, pulmonary, cardiovascular or endocrine systems
• A second child within a family in which a sibling has already been enrolled.
• A child who has previously participated in the CAMP-01 study

Where it is running

• Melmed Center — Scottsdale, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• UC David MIND Institute — Sacramento, California, United States
• Lurie Center for Autism — Lexington, Massachusetts, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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