NCT06706934

Brief Summary

Each form of intellectual disability under study is a rare disease in its own right, and it is therefore difficult to study the variability of its expression. It therefore appears necessary to study large series of patients with intellectual disabilities. The objective is to identify variants in phenotype-modifying genes in patients with intellectual disability.

Trial Health

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Trial Health Score

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

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Mar 2025Jul 2027

First Submitted

Initial submission to the registry

November 22, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 27, 2025

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

November 22, 2024

Last Update Submit

February 26, 2025

Conditions

Intellectual Disability

Keywords

Intellectual Disabilityepistatic interaction

Outcome Measures

Primary Outcomes (1)

  • Variants in phenotype-modifying genes

    Identifying variants in phenotype-modifying genes in patients with intellectual disability.

    Inclusion visit

Secondary Outcomes (1)

  • Phenotypic traits

    Inclusion visit

Study Arms (2)

Patients

Patients group with intellectual disability

Control

Control group without intellectual disability

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with intellectual disabilities or related but not affected by them

You may qualify if:

  • Patients with Intellectual Disability or related but not affected by them
  • Major or minor with autorisation of legal representative
  • Exome sequencing in Bordeaux University Hospital between 2018 and 2024

You may not qualify if:

  • Refusal to participate in research protocols
  • Refusal to participate expressed following receipt of information letter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Vincent MICHAUD, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent MICHAUD, MD

CONTACT

+33556795952vincent.michaud@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 27, 2024

Study Start

March 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 27, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)