MedPath

Susceptibility Genes in Autism Spectrum Disorders

Completed
Conditions
Autism Spectrum Disorders
Registration Number
NCT02628808
Lead Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Brief Summary

The main objective of the study is to define, for Autism Spectrum Disorder, the extent of genetic variation in synaptic pathways that may be targeted for therapeutic development. For this purpose the investigators will take advantage of large, well-characterized cohorts of patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of selected synaptic genes, previously associated with Autism Spectrum Disorder, will be carried out in these cohorts with deep coverage of coding regions and a strong focus on previously untested regulatory regions. Genomic data from Copy Number Variant, whole genome sequencing and exome sequencing, available for some of these patients, will be integrated in the overall analysis. The investigators will strongly emphasize the establishment of comprehensive genotype/phenotype correlations and set up an induced Pluripotent Stem Cells collection from selected patients with synaptic mutations for functional and expression analysis.

Detailed Description

Specific aims are:

Aim 1: To identify genetic variants in selected synaptic genes, by targeted sequencing with deep coverage of coding regions and a strong focus on previously untested regulatory regions in Autism Spectrum Disorder

Aim 2: To define the range of clinical phenotypes caused by mutations in synaptic genes by establishing detailed genotype/phenotype correlations and analyzing segregation in families with multiple individuals affected by Autism Spectrum Disorder, Autism Spectrum Disorder traits or other neuropsychiatric disorders

Aim 3: To generate a repository of induced Pluripotent Stem Cells from Autism Spectrum Disorder subjects with synaptic mutations for translational studies, including expression and functional assays.

Aim 4: To identify the neuronal phenotypes caused by deleterious synaptic mutations for further translational studies

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1616
Inclusion Criteria
  • Diagnosis for Autism Spectrum Disorders or Autism using the Autism Diagnostic Interview-Revised (ADI-R) criteria for autism and Autism Diagnostic Observation Schedule (ADOS-G) criteria
Exclusion Criteria
  • Patients with profound intellectual disability or with a known medical cause of autism, such as neurocutaneous syndromes, Fragile X, metabolic disorders, extreme prematurity, congenital rubella and other prenatal or postnatal neurological infections or gross dysmorphology, will be excluded

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Prevalence of synaptic gene deleterious mutations in patients with Autism Spectrum Disorderup to 12 months after completion of the inclusion and molecular explorations
Secondary Outcome Measures
NameTimeMethod
Prevalence of the deleterious mutations in the major biological pathways in Autism Spectrum Disorders:up to 12 months after completion of the inclusion and molecular explorations)

The deleterious mutations that the investigators will identify in genes related to Autism Spectrum Disorders will help to have a comprehensive framework of biological pathways involved in Autism Spectrum Disorder

Trial Locations

Locations (5)

Centre de Ressources Autisme Aquitaine, CHU de Bordeaux

🇫🇷

Bordeaux, France

CADIPA Centree hospitalier de Saint Egreve

🇫🇷

Grenoble, France

Cic Henri Mondor

🇫🇷

Paris, France

Albert Chenevier Hospital

🇫🇷

Creteil, Ile De France, France

Robert Debré Hospital

🇫🇷

Paris, Ile De France, France

© Copyright 2025. All Rights Reserved by MedPath