Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03587493 |
| Other study ID # |
2018-09 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 13, 2018 |
| Est. completion date |
September 2022 |
Study information
| Verified date |
October 2021 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
BENJAMIN COIFFARD, MD |
| Phone |
+33 491964355 |
| Email |
Benjamin.COIFFARD[@]ap-hm.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
