Exploring the Physiological Mechanisms of Austism Through Organoids

NCT07494331 | Not Yet Recruiting

• 2 other identifiers: APHP2509832025-A01511-48
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder affecting approximately 1% of the population, characterized by difficulties with social interaction and communication. Studies have identified more than 200 genes linked to ASD, particularly those involved in chromatin remodeling and synaptic neuronal connectivity (CHD8, SCN2A, NLGN3-4X, SHANK1-3). The goal of the project is to decipher the biological mechanisms underlying ASD in order to develop therapeutic strategies, using innovative preclinical models such as organoids.

Conditions

Autism Spectrum Disorder (ASD

Keywords

ASD; organoid

Outcome Measures

Primary Outcomes (1)

• Production of organoïds

  To study the cellular mechanisms affected by the presence of the abnormalities identified in the participant with ASD

  2 years

Study Arms (1)

Cohort of patients

Blood sample and quetsionnaire if required by the investigator

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A child with an autism spectrum disorder, a sibling over the age of 2 who does not have an autism spectrum disorder, and biological parents

You may qualify if:

• A child diagnosed with an autism spectrum disorder in accordance with clinical practice guidelines
• A sibling without an autism spectrum disorder (SRS \< 65)
• Biological parents
• Children and parents must be enrolled in a social security program, Universal Health Coverage (CMU), or an equivalent program.

You may not qualify if:

• Refusal to undergo a blood test
• Uncontrolled (unstabilized) medical condition (including psychiatric conditions) that precludes participation in the study
• Sibling with an SRS score \> 65 at screening or under 2 years old

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for peripheral blood monoculear cells (PBMC) extraction.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Richard DELORME, Prof

CONTACT

0033(0)140034130; richard.delorme@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)