Study of the Genetic Factors Involved in Autism and Related Disorders

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Genetic
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 70
Healthy Volunteers: t
View:

⁃ Probands with Autism Spectrum Disorder

• Meet the diagnostic criteria for ASD of the DSM-5 \[American Psychiatric Association, 2013\] based on a consensus between the clinical expertise of expert clinicians, the scores of the Autism Diagnostic Interview-Revised (ADI-R) (Rutter et al, 2003) and those of the Autism Diagnosis Observation Schedule (ADOS-2) (Lord et al, 2012)

• Be at least 24 months (no upper age limit)

• Somatic and Intellectual state compatible with a blood test

• Affiliation to the social insurance

• Signature of informed consent by the applicant or by holders of parental authority if the subject is a minor or by the guardian if the subject is under guardianship

⁃ Controls without ASD

• At least 24 months old

• Somatic and Intellectual state compatible with a blood test

• Affiliation to the social insurance

• Signature of informed consent by the subject or by holders of parental authority if the subject is a minor or by the guardian if the subject is under guardianship

⁃ Relatives of the probands with ASD or of controls without ASD

• At least 24 months old

• Somatic and Intellectual state compatible with a blood test

• Affiliation to the social insurance

• Signature of informed consent by the subject or by holders of parental authority if the subject is a minor or by the guardian if the subject is under guardianship

Locations
Other Locations
France
CIC, CHU Bordeaux
RECRUITING
Bordeaux
CRA, Hopital Charles Perrens, Bordeaux
RECRUITING
Bordeaux
Albert Chenevier Hospital
NOT_YET_RECRUITING
Créteil
CIC, H. Mondor, Creteil
NOT_YET_RECRUITING
Créteil
Centre de rehabilitation psychosociale, Hopital Saint Egreve
NOT_YET_RECRUITING
Grenoble
Robert Debré Hospital
NOT_YET_RECRUITING
Paris
Contact Information
Primary
Richard Delorme, M.D, Ph.D
richard.delorme@aphp.fr
+33662725334
Backup
Marion Leboyer, M.D, Ph.D
marion.leboyer@inserm.fr
+33149813131
Time Frame
Start Date: 2021-03-30
Estimated Completion Date: 2036-03
Participants
Target number of participants: 3800
Treatments
Autism Spectrum Disorder
Probands with Autism Spectrum Disorder, (N=700), Diagnosis of ASD according to DSM-V criteria For 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.
Control without Autism Spectrum Disorder
Controls without Austim Spectrum Disorder, aged 6 to 40, N=2100 (300 adultes, 300 children) 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).
Relatives of probands with Autism Spectrum Disorder
Relatives of probands with Autism Spectrum Disorder (N=1200 parents, N=600 siblings, N=300 other relatives)~* Without Autism Spectrum Disorder diagnosis according to DSM-V,~* With Autism Spectrum Disorder diagnosis according to DSM-V, and 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
Relatives of controls
Relatives of controls without Autism Spectrum Disorder, N=400 first degree relatives
Related Therapeutic Areas
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France

This content was sourced from clinicaltrials.gov