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NCT Number: NCT07494331

Exploring the Physiological Mechanisms of Austism Through Organoids

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.

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Key information

Conditions

Autism Spectrum Disorder (ASD Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Each participant's involvement in this study is limited to one visit. This study requires only a blood draw (5 to 30 minutes), which will be performed at the CIC at Robert-Debré, and the completion of questionnaires for parents (SRS) and unaffected siblings (SRS, ADHD-RS, SDQ). Additional tests or questionnaires may be offered at a later stage if clinically necessary.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Production of organoïds

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Richard DELORME, Prof

CONTACT

[email protected]

0033(0)140034130

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Exploring the Physiologicla Mechainisms of Austism Through Organoids Derived Differentiated Cells of Individuals With Autism

Acronym: EXPECT HYPE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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