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

• Sponsor: Institut Jerome Lejeune (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05767203
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 124
• Patients Per Site Per Month: 16.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome; Intellectual Disability	Other: Biological samplings	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2032
• Anticipated Study Completion Date: Dec 31, 2032

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Identification of biomarkers in blood [10 years]

   Analysis of biomarkers from blood samples taken during the visit

2. Identification of biomarkers from skin samples [10 years]

   Analysis of biomarkers from skin samples taken during the visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jérôme Lejeune	Paris		France	75015

Sponsors and Collaborators

• Institut Jerome Lejeune

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Jerome Lejeune
• ClinicalTrials.gov Identifier: NCT05767203
• Other Study ID Numbers: BioJeL
• First Posted: Mar 14, 2023
• Last Update Posted: Mar 14, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Down Syndrome; Intellectual Disability

Study Results

No Results Posted as of Mar 14, 2023