Genetic Markers and Biomarkers in Patients With Intellectual Disabilities of Genetic Origin (BioJeL)

March 1, 2023 updated by: Institut Jerome Lejeune

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Blood and/or skin samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of biomarkers in blood
Time Frame: 10 years
Analysis of biomarkers from blood samples taken during the visit
10 years
Identification of biomarkers from skin samples
Time Frame: 10 years
Analysis of biomarkers from skin samples taken during the visit
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Jerome Lejeune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2032

Study Completion (Anticipated)

December 31, 2032

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BioJeL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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