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Clinical Trials/NCT04043351
NCT04043351
Completed
Not Applicable

Diagnostic Performance of Exome Sequencing in Autism Spectrum Disorders

University Hospital, Rouen1 site in 1 country300 target enrollmentJune 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University Hospital, Rouen
Enrollment
300
Locations
1
Primary Endpoint
Proportion of unrelated index cases
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

Evaluation of the diagnostic performance of exome sequencing in a prospective series of patients with autism spectrum disorders (ASD).

Registry
clinicaltrials.gov
Start Date
June 12, 2019
End Date
October 19, 2021
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient with ASD who has been previously diagnosed by an expert center according to the DSM5 criteria using standardized instruments (ADOS, ADI-R), referred to genetic consultation by the psychiatrist who performed the clinical diagnosis, according to the recommendations of the HAS, and requesting a genetic analysis for medical purposes in this context.
  • Patient over 3 years old
  • Patient affiliated to a social security scheme
  • For minor patients: Holders of the exercise of parental authority who have read and understood the newsletter and signed the consent form
  • For a major patient: Major patient who has read and understood the newsletter and signed the consent form
  • Supervised minor / minor patient: Legal representative who has read and understood the newsletter and signed the consent form
  • Major patient under guardianship: Major patient assisted by his curator or by the judge having read and understood the newsletter and signed the consent form
  • DNA of the patient and parents available

Exclusion Criteria

  • Patient who has already benefited from exome sequencing
  • Person deprived of liberty by an administrative or judicial decision
  • Pregnant or lactating woman

Outcomes

Primary Outcomes

Proportion of unrelated index cases

Time Frame: through study completion, an average of 4 years

at least one definite or probable risk factor or causal variant of a monogenic form of autism

Study Sites (1)

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