Clinical Trials Logo

Clinical Trial Summary

The objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7). 110 adults over 18 years, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg, whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Peripheral venous blood sampling just prior to pulmonary transplantation, at day 15 and one month post-transplant will be realized for lymphocyte phenotyping by flow cytometry (CD45, CD3, CD4, CD8, CD19, HLA-DR, CD25, CD38, CD45RO, CCR7). Acute rejection will be evaluated at 1 month and 1 year post-transplant by trans-bronchial biopsies. The two main perspectives are to 1) find a specific, non-invasive, blood-based diagnostic marker of acute post-lung transplant rejection with diagnostic performance equivalent to trans-bronchial biopsy 2) demonstrate a specific blood marker, non-invasive, predictive of acute rejection in order to adapt immunosuppressive therapy early and reduce the occurrence of this risk.


Clinical Trial Description

The objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7). 110 adults over 18 years, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg (France), whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Peripheral venous blood sampling just prior to pulmonary transplantation, at day 15 and one month post-transplant will be realized for lymphocyte phenotyping by flow cytometry (CD45, CD3, CD4, CD8, CD19, HLA-DR, CD25, CD38, CD45RO, CCR7). Acute rejection will be evaluated at 1 month and 1 year post-transplant by trans-bronchial biopsies. The two main perspectives are to 1) find a specific, non-invasive, blood-based diagnostic marker of acute post-lung transplant rejection with diagnostic performance equivalent to trans-bronchial biopsy 2) demonstrate a specific blood marker, non-invasive, predictive of acute rejection in order to adapt immunosuppressive therapy early and reduce the occurrence of this risk. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03587493
Study type Interventional
Source Assistance Publique Hopitaux De Marseille
Contact BENJAMIN COIFFARD, MD
Phone +33 491964355
Email Benjamin.COIFFARD@ap-hm.fr
Status Recruiting
Phase N/A
Start date August 13, 2018
Completion date September 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06080490 - Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
Recruiting NCT06116721 - Evaluation of APOL1 Gene Variants in Kidney Donors and Their Impact on Long-term Renal Function in Donors and Recipients
Enrolling by invitation NCT04217343 - NCAMR-CAMR Allosure Study
Completed NCT04783818 - Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Completed NCT04854525 - Breast Reconstruction in Previously Irradiated Breast
Recruiting NCT06346665 - The Transplant Cohort of the German Center for Infection Research
Completed NCT03723317 - Associated Balance of Risk Score - Comprehensive Complication Index for the Prediction of Post-transplant Survival
Active, not recruiting NCT03882164 - Blood-Bile Ratio Tacrolimus After Liver Transplantation
Recruiting NCT04360031 - The Effects of Microbiota Composition on Immunosuppression Protocols in Transplantation
Active, not recruiting NCT03575910 - HEARTBiT: Multi-Marker Blood Test for Acute Cardiac Transplant Rejection
Active, not recruiting NCT05184426 - MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)