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Autism Spectrum DisordersNCT02628808

Susceptibility Genes in Autism Spectrum Disorders

An observational study of Autism Spectrum Disorders, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 months to 70 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorders
How many people
1,616 participants
Where
5 sitesFrance
Study dates
4 Feb 2009to 3 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: For all patients included in the study, .

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites
  • Centre de Ressources Autisme Aquitaine, CHU de Bordeaux

    Bordeaux

  • Albert Chenevier Hospital

    Créteil, Île-de-France Region, 94000

  • CADIPA Centree hospitalier de Saint Egreve

    Grenoble

  • Cic Henri Mondor

    Paris

  • Robert Debré Hospital

    Paris, Île-de-France Region, 75019

Other trials in France

About this study

Official title: Search of Susceptibility Genes in Autism Spectrum Disorders

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.

Read the 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

Keywords
autism, asperger, Pervasive Developmental Disorder No Otherwise Specify, gene, polymorphism, mutation
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02628808
Study groupRoleWhat they receive
Autism Spectrum DisorderFor all patients included in the study, core assessment carried out by either collaborating partners consists of diagnosis using the Autism Diagnostic Interview-Revised (ADI-R) criteria for autism and Autism Diagnostic Observation Schedule (ADOS-G) criteria for autism or Autism Spectrum Disorders. 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.
controlsAge 2 to 65 Healthy individuals with or without idiopathic surgical or urological conditions (e.g. orthopaedic conditions, hernia repairs, renal malformations, pre- or post-circumcision, phimosis, balanitis, scoliosis, congenital hip dislocation, adenoid or tonsil removal, dental procedures such as wisdom tooth extraction, cosmetic procedures such as removal of skin tags or cleft lip repairs, non-head injuries such as fractures, drainage of subungual or perichondrial haematomata).
relativesAny familly members of included patient, aged of 2 or more. Exept persons with profound intellectual disability

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (1)
  1. Prevalence of the deleterious mutations in the major biological pathways in Autism Spectrum Disorders:

    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

    Measured: up to 12 months after completion of the inclusion and molecular explorations)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2015 (estimated)
  2. Study start4 Feb 2009
  3. Primary completion3 Dec 2021
  4. Study completion3 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
1,616 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02628808
Sponsor's protocol ID
C07-33
Other IDs
2008-A00019-46
Status last verified
Feb 2025
First submitted
26 Sep 2013
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Delorme R, Ey E, Toro R, Leboyer M, Gillberg C, Bourgeron T. Progress toward treatments for synaptic defects in autism. Nat Med. 2013 Jun;19(6):685-94. doi: 10.1038/nm.3193. Epub 2013 Jun 6.

    PubMed 23744158
  • Bennabi M, Tarantino N, Gaman A, Scheid I, Krishnamoorthy R, Debre P, Bouleau A, Caralp M, Gueguen S, Le-Moal ML, Bouvard M, Amestoy A, Delorme R, Leboyer M, Tamouza R, Vieillard V. Persistence of dysfunctional natural killer cells in adults with high-functioning autism spectrum disorders: stigma/consequence of unresolved early infectious events? Mol Autism. 2019 May 15;10:22. doi: 10.1186/s13229-019-0269-1. eCollection 2019.

    PubMed 31123562
  • Baltazar M, Geoffray MM, Chatham C, Bouvard M, Martinez Teruel A, Monnet D, Scheid I, Murzi E, Couffin-Cadiergues S, Umbricht D, Murtagh L, Delorme R, Ly Le-Moal M, Leboyer M, Amestoy A. "Reading the Mind in the Eyes" in Autistic Adults is Modulated by Valence and Difficulty: An InFoR Study. Autism Res. 2021 Feb;14(2):380-388. doi: 10.1002/aur.2390. Epub 2020 Sep 15.

    PubMed 32929870
  • Laidi C, Neu N, Watilliaux A, Martinez-Teruel A, Razafinimanana M, Boisgontier J, Hotier S, d'Albis MA, Delorme R, Amestoy A, Holiga S, Moal ML, Coupe P, Leboyer M, Houenou J, Rondi-Reig L, Paradis AL. Preserved navigation abilities and spatio-temporal memory in individuals with autism spectrum disorder. Autism Res. 2023 Feb;16(2):280-293. doi: 10.1002/aur.2865. Epub 2022 Dec 9.

    PubMed 36495045
  • Lefebvre A, Traut N, Pedoux A, Maruani A, Beggiato A, Elmaleh M, Germanaud D, Amestoy A, Ly-Le Moal M, Chatham C, Murtagh L, Bouvard M, Alisson M, Leboyer M, Bourgeron T, Toro R, Dumas G, Moreau C, Delorme R. Exploring the multidimensional nature of repetitive and restricted behaviors and interests (RRBI) in autism: neuroanatomical correlates and clinical implications. Mol Autism. 2023 Nov 27;14(1):45. doi: 10.1186/s13229-023-00576-z.

    PubMed 38012709
  • Holiga S, Hipp JF, Chatham CH, Garces P, Spooren W, D'Ardhuy XL, Bertolino A, Bouquet C, Buitelaar JK, Bours C, Rausch A, Oldehinkel M, Bouvard M, Amestoy A, Caralp M, Gueguen S, Ly-Le Moal M, Houenou J, Beckmann CF, Loth E, Murphy D, Charman T, Tillmann J, Laidi C, Delorme R, Beggiato A, Gaman A, Scheid I, Leboyer M, d'Albis MA, Sevigny J, Czech C, Bolognani F, Honey GD, Dukart J. Patients with autism spectrum disorders display reproducible functional connectivity alterations. Sci Transl Med. 2019 Feb 27;11(481):eaat9223. doi: 10.1126/scitranslmed.aat9223.

    PubMed 30814340
  • Lefebvre A, Tillmann J, Cliquet F, Amsellem F, Maruani A, Leblond C, Beggiato A, Germanaud D, Amestoy A, Ly-Le Moal M, Umbricht D, Chatham C, Murtagh L, Bouvard M, Leboyer M, Charman T, Bourgeron T, Delorme R, Dumas G; and the EU-AIMS LEAP group. Tackling hypo and hyper sensory processing heterogeneity in autism: From clinical stratification to genetic pathways. Autism Res. 2023 Feb;16(2):364-378. doi: 10.1002/aur.2861. Epub 2022 Dec 4.

    PubMed 36464763
  • Safra L, Ioannou C, Amsellem F, Delorme R, Chevallier C. Distinct effects of social motivation on face evaluations in adolescents with and without autism. Sci Rep. 2018 Jul 13;8(1):10648. doi: 10.1038/s41598-018-28514-7.

    PubMed 30006527
  • Amestoy A, Guillaud E, Bucchioni G, Zalla T, Umbricht D, Chatham C, Murtagh L, Houenou J, Delorme R, Moal ML, Leboyer M, Bouvard M, Cazalets JR. Visual attention and inhibitory control in children, teenagers and adults with autism without intellectual disability: results of oculomotor tasks from a 2-year longitudinal follow-up study (InFoR). Mol Autism. 2021 Nov 13;12(1):71. doi: 10.1186/s13229-021-00474-2.

    PubMed 34774105
  • Latimier A, Kovarski K, Peyre H, Fernandez LG, Gras D, Leboyer M, Zalla T. Trustworthiness and Dominance Personality Traits' Judgments in Adults with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Nov;49(11):4535-4546. doi: 10.1007/s10803-019-04163-1.

    PubMed 31418129
  • Grea H, Scheid I, Gaman A, Rogemond V, Gillet S, Honnorat J, Bolognani F, Czech C, Bouquet C, Toledano E, Bouvard M, Delorme R, Groc L, Leboyer M. Clinical and autoimmune features of a patient with autism spectrum disorder seropositive for anti-NMDA-receptor autoantibody. Dialogues Clin Neurosci. 2017 Mar;19(1):65-70. doi: 10.31887/DCNS.2017.19.1/mleboyer.

    PubMed 28566948

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorders, run by Institut National de la Santé Et de la Recherche Médicale, France at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02628808, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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