Constitution of a Biobank for Studies Related to Organ Transplantation (Lyon Centaure Biocollection)

Organ Transplantation Clinical Trial

Official title:

Biological Material Bank for Studies Related to Organ Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04687865
• Other study ID #: 69HCL20_0964
• Status: Recruiting
• Start date: January 8, 2020
• Est. completion date: January 8, 2040

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Olivier Thaunat, MD
• Phone: 04 72 11 69 28
• Email: olivier.thaunat[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order :

i) validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions (such as BK virus nephropathy, Post-transplant lymphoproliferative disorder ( PTLD) ...)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 8, 2040
• Est. primary completion date: January 8, 2040
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or Female patient =18 years old

• Recipient of an organ transplant

• Written informed consent

Exclusion Criteria:

• Non-affiliation to a social security system.

• Subjects deprived of liberties

• Pregnant or breastfeeding woman

Related Conditions & MeSH terms

• Organ Transplantation

Intervention

Other:
• Biobank
For each patient included in the study the following samples will be collected at the indicated time points after transplantation: Serum samples and plasma sample: Day1, Month 1, Month 3, Month 6, Month 12, month 60, month 120 and at the time of each allograft biopsy. Urines samples: Month 3 and Month 12 and at the time of each allograft biopsy. Peripheral Blood Mononuclear Cell (PBMC): for each organ allograft biopsy. Allograft biopsies: systematically at Month 3, and Month 12, and for cause in case of allograft dysfunction.

Locations

Country	Name	City	State
France	Hopital Edouard Herriot	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the biological samples	The goal of this study is to provide biological materials from transplanted patients	At inclusion
Primary	Change Biological Samples	The goal of this study is to provide biological materials from transplanted patients	Month 1
Primary	Change Biological Samples	The goal of this study is to provide biological materials from transplanted patients	Month 3
Primary	Change Biological Samples	The goal of this study is to provide biological materials from transplanted patients	Month 6
Primary	Change Biological Samples	The goal of this study is to provide biological materials from transplanted patients	Month 12
Primary	Change Biological Samples	The goal of this study is to provide biological materials from transplanted patients	Month 60
Primary	Change Biological Samples	The goal of this study is to provide biological materials from transplanted patients	Month 120