NCT07427940 Omic Profile in Autism Spectrum Disorder: From Cellular Level Towards Future Treatments
| NCT ID | NCT07427940 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-31 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-08-31 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an interventional non pharmacological study in pediatric patientis affected by Autism Spectrum Disorder. It ams to create a collection of iPSCs and hiNSCs derived from deeply characterized ASD patients, to omics-characterize the cells, and to study the behavioral pattern of microglia-like cells in the onset of ASD.
Eligibility Criteria
Inclusion Criteria: * Defined ASD diagnosis according to DSM-5 criteria * Age 3-15 years * Informed consent signed by the guardians/legal representatives. Exclusion Criteria: * Exclusion criteria for Group 1 will be: having a defined genetic diagnosis or an overall clinical presentation strongly suggestive for a syndromic condition. For this definition we will apply the criteria ASD associated with at least one of the following: \>=3 facial anomalies, \>=1 major/\>=2 minor malformation (following EUROCAT classification), clinical issue affecting \>=2 systems. Children showing such phenotypes but having no current genetic diagnosis could not be included in the study. Patients with a syndromic presentation and confirmed genetic diagnosis will be included in the Syndromic Group 2. * No standardized test to establish diagnosis * Parents refusing to complete the consent form * Impossible blood sample collection.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07427940 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 15 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07427940 currently recruiting?
Yes, NCT07427940 is actively recruiting participants. Contact the research team at stefano.darrigo@istituto-besta.it for enrollment information.
Where is the NCT07427940 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07427940 clinical trial?
NCT07427940 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The trial plans to enroll 100 participants.