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

NCT04687865 | Recruiting

• 1 other identifier: 69HCL20_0964
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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) ...)

Conditions

Organ Transplantation

Outcome Measures

Primary Outcomes (7)

• the biological samples

  The goal of this study is to provide biological materials from transplanted patients

  At inclusion

• Change Biological Samples

  The goal of this study is to provide biological materials from transplanted patients

  Month 1

• Change Biological Samples

  The goal of this study is to provide biological materials from transplanted patients

  Month 3

• Change Biological Samples

  The goal of this study is to provide biological materials from transplanted patients

  Month 6

• Change Biological Samples

  The goal of this study is to provide biological materials from transplanted patients

  Month 12

• Change Biological Samples

  The goal of this study is to provide biological materials from transplanted patients

  Month 60

• Change Biological Samples

  The goal of this study is to provide biological materials from transplanted patients

  Month 120

Interventions

Biobank OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients that received a solid organ transplant at the transplantation department of Lyon University Hospital

You may qualify if:

• Male or Female patient ≥18 years old
• Recipient of an organ transplant
• Written informed consent

You may not qualify if:

• Non-affiliation to a social security system.
• Subjects deprived of liberties
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Edouard Herriot

Lyon, Rhône, 69003, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for DNA

MeSH Terms

Interventions

Biological Specimen Banks

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Olivier Thaunat, MD

  Edouard Herriot Hospital - Transplantation department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Thaunat, MD

CONTACT

04 72 11 69 28; olivier.thaunat@chu-lyon.fr

Emmanuel Morelon, MD

CONTACT

04 72 11 01 70; emmanuel.morelon@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 29, 2020
• Study Start: January 8, 2020
• Primary Completion (Estimated): January 8, 2040
• Study Completion (Estimated): January 8, 2040
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

FR (1)