Clinical trial · Observational
Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders
NCT04322734CI-TRIAL-00109192recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study involves up to 5 visits for a fasting blood draw, behavioral assessments, and/or questionnaires. Other samples may be collected when appropriate. This study is currently recruiting. There is no cost for visits or study-related exams.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autism Spectrum Disorder | — | UNRESOLVED | — |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Epilepsy | — | UNRESOLVED | — |
| Mitochondrial Diseases | — | UNRESOLVED | — |
| Mitochondrial Pathology | — | UNRESOLVED | — |
| Psychiatric Disorder | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (9)
- label
- ASD (General)
- description
- 150 children with ASD and unknown MD status
- label
- ASD (With MD)
- description
- 50 children with ASD and confirmed MD
- label
- ASD (No MD)
- description
- 50 children with ASD and ruled out MD
- label
- Epilepsy
- description
- 50 children with epilepsy (primary) and no ASD
- label
- Brain Tumor
- description
- 50 children with brain tumor (primary) and no ASD
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (ASD): 1. ASD, as defined by either a gold standard measure for ASD diagnosis, the Autism Diagnostic Observation Schedule (ADOS); the Autism Diagnostic Interview-Revised (ADI-R); and/or a comprehensive assessment that is consistent with ASD, in the opinion of the principal investigator. For those the PI believes a prospective diagnosis of ASD is warranted, a formal diagnostic assessment will be scheduled at screening. 2. 0 years through 17 years 11 months of age Inclusion Criteria (TD, MD, Epilepsy, Brain Tumor, Psychiatric) 1\. 0 years to 17 years 11 months of age Exclusion Criteria (All): 1. History of a significant adverse reaction to a prior blood draw 2. In females of reproductive age, pregnancy or plans to become pregnant 3. Any other historical event/information that may, in the opinion of the PI, be a reason to exclude the child from participation.
References
Publications (0)
Data not yet available
No reference posted for this study.