NCT04923854

Brief Summary

Autism Spectrum Disorders (ASD) are a heterogeneous group of severe developmental abnormalities of the nervous system characterized by deficits in social interaction and verbal and nonverbal communication affecting approximately 1% of the general population. In 5-40% of cases, genetic factors are identified as the cause of these disorders. Despite this unique definition and the advancement of techniques, ASD is still a clinically and genetically heterogeneous condition, as several hundred genes have been identified to date. Primary Objective and Endpoint Primary Objective: Exploration of phenotypic heterogeneity in patients with ASD. Primary endpoint:

  • Routine Care Clinical Investigation Criteria.
  • Scores on assessment scales,

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2021Jul 2027

First Submitted

Initial submission to the registry

June 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 18, 2022

Status Verified

May 1, 2021

Enrollment Period

5 years

First QC Date

June 7, 2021

Last Update Submit

April 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The main objective is to better understand the phenotypic heterogeneity of Autism Spectrum Disorder (ASD).

    DSM5 (Diagnostic statistical Manual of Mental disorders) Autism diagnostic scales

    12 months

Interventions

No intervention

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

child (age \<18 years) with Autism Spectrum Disorder

You may qualify if:

  • child (age \<18 years) with Autism Spectrum DisorderAutism Spectrum Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Robert Debré

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Richard DELORME, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard DELORME, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 11, 2021

Study Start

July 1, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

April 18, 2022

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations