Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)

Launched by BENJAMIN GESUNDHEIT · Jun 19, 2014

Keywords

ClinConnect Summary

This clinical trial is looking at ways to improve the diagnosis of Autism Spectrum Disorder (ASD) in children. Currently, diagnosing ASD relies on behavioral tests that can be subjective and require trained professionals, making them time-consuming. The goal of this study is to see if blood, urine, or stool tests can provide a more objective way to diagnose ASD, potentially even before any symptoms appear. This could help identify ASD earlier, allowing for earlier intervention and support, which is important for the child's development.

To participate in the trial, children aged 2 to 12 who have been diagnosed with ASD are eligible, as well as younger siblings of children with ASD and typically developing children aged 2 to 12. Parents must provide informed consent for their child to take part. Participants will help researchers understand the biological factors related to ASD and the potential for new types of diagnostic testing. It’s important to note that children or mothers with certain health conditions, like severe infections or recent treatments that affect the immune system, cannot participate in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female children
• • 2. Child aged 2-12 years with diagnosed ASD according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (299.00) or DSM-V (299.00) OR Child aged 2-18 years diagnosed ASD according to DSM-IV (299.00) or DSM-V (299.00) AND scheduled to undergo stem cell transplantation OR Child aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD according to (DSM)-IV (299.00) or DSM-V (299.00) (herein termed "high-risk infants") OR Mothers of recruited high-risk infants OR A typically developing child aged 2-12 years with no signs of ASD or history of ASD in the immediate family
• • 3. Informed consent signed by the parent/legal guardian
• Exclusion Criteria:
• • 1. Child and/or mother completed treatment with systemic steroids or immune suppressants less than 4 weeks before the screening visit
• • 2. Child and/or mother diagnosed with severe infectious diseases or sepsis over the last 6 months
• • 3. Child with ASD treated for a severe convulsive disorder (intractable seizures)
• • 4. Child and/or mother with hematological or malignant disorder
• • 5. For children in the SCT cohort: No new planned immune-modulating treatment (other than SCT) for at least 6 months before or after planned stem cell transplantation date
• • 6. If the PI suspects that the participant will not comply with study requirements, the participant may be excluded.