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NCT05767203 Clinical Trial

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

Down Syndrome Clinical Trial

— BioJeL  

Official title:
Search for Genetic Markers and Biomarkers to Follow Patients With Intellectual Disabilities of Genetic Origin and to Understand Its Origin and Associated Comorbidities

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05767203
Other study ID # BioJeL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 31, 2032

Study information
Verified date March 2023
Source Institut Jerome Lejeune
Contact Sophie Durand
Phone +33156586300
Email sophie.durand@institutlejeune.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 31, 2032
Est. primary completion date September 1, 2032
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Biological samplings
Blood and/or skin samples

Locations
Country Name City State
France Institut Jérôme Lejeune Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut Jerome Lejeune

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of biomarkers in blood Analysis of biomarkers from blood samples taken during the visit 10 years
Primary Identification of biomarkers from skin samples Analysis of biomarkers from skin samples taken during the visit 10 years
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