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RecruitingNCT05767203BioJeLUpdated Mar 14, 2023

Genetic Markers and Biomarkers in Patients With Intellectual Disabilities of Genetic Origin

An interventional study of Biological samplings in Down Syndrome and Intellectual Disability, sponsored by Institut Jerome Lejeune. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Institut Jerome Lejeune · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2022, registered Feb 2023).
  • Started Sep 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Not applicable
Sex
All
01

Study summary

Analyze genetic and biological markers in patients with Intellectual Deficiencies (ID) of genetic origin in order to better understand the mechanisms of modified genes, cellular mechanisms, pathways involved in different disorders , complications and pathologies associated with ID of genetic origin.

Read the detailed description

Blood and skin samples will be taken from patients coming at the outpatients clinic of the Institut Jérôme Lejeune and who consent to participate to the study. Search and identification of markers will be then done from the collected samples.

02

Conditions studied

  • Down Syndrome
  • Intellectual Disability
03

In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 36 across 283 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

Institut Jerome Lejeune is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patient diagnosed with an intellectual disability of genetic origin
  • Patient of all ages coming for consultation at the Institut Jérôme Lejeune
  • Patient whose parents or legal representative have received and understood the information document and signed the informed consent for a sample for the research project.
  • Patient affiliated to a social security scheme

Exclusion criteria

Exclusion Criteria:

  • Parents unable to find out about the constraints related to the study
  • Refusal of informed patient participation
  • Pregnant, parturient and nursing mothers
  • Persons deprived of their liberty by judicial or administrative decision
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    Patients with Down syndrome or other Intellectual deficiency of genetic origin

    Patients with Down syndrome or with other intellectual deficiency of genetic origin followed at the outpatients clinic of the Institut Jérôme Lejeune.

    Other: Biological samplings

Interventions

  • OtherBiological samplings

    Blood and/or skin samples

06

What researchers measure

Primary outcomes

  1. Identification of biomarkers in blood

    Analysis of biomarkers from blood samples taken during the visit

    Time frame: 10 years

  2. Identification of biomarkers from skin samples

    Analysis of biomarkers from skin samples taken during the visit

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05767203
Lead sponsor
Institut Jerome Lejeune
Responsible party
Sponsor
First posted
Mar 14, 2023
Start date
Sep 1, 2022
Primary completion
Sep 1, 2032 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Mar 14, 2023

Study contacts

Sophie Durand
Contact
sophie.durand@institutlejeune.org
+33156586300

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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