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Clinical Trials/NCT02628808
NCT02628808
Completed
N/A

Search of Susceptibility Genes in Autism Spectrum Disorders

Institut National de la Santé Et de la Recherche Médicale, France5 sites in 1 country1,616 target enrollmentFebruary 4, 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorders
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
1616
Locations
5
Primary Endpoint
Prevalence of synaptic gene deleterious mutations in patients with Autism Spectrum Disorder
Status
Completed
Last Updated
5 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 4, 2009
End Date
December 3, 2021
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Prevalence of synaptic gene deleterious mutations in patients with Autism Spectrum Disorder

Time Frame: up to 12 months after completion of the inclusion and molecular explorations

Secondary Outcomes

  • 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))

Study Sites (5)

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