T-lymphocytes CD8+/HLA-DR+ and Acute Rejection After Lung Transplantation
Activated Cytotoxic T-lymphocytes CD8+/HLA-DR+ and Acute Cellular Rejection After Lung Transplantation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: BENJAMIN COIFFARD, MD
- Phone Number: +33 491964355
- Email: Benjamin.COIFFARD@ap-hm.fr
Study Locations
-
-
Paca
-
Marseille, Paca, France, 13354
- Recruiting
- Assistance Publique des Hôpitaux de Marseille
-
Contact:
- BENJAMIN COIFFARD, MD
- Phone Number: +33 491964355
- Email: Benjamin.COIFFARD@ap-hm.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- >18 years old
- French national waiting list of lung transplantation
- Transplanted in Marseille or Strasbourg (France)
Exclusion Criteria:
- <18 years old
- Refused to participate
- Redo lung transplantation
- Other organ transplanted
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EXPERIMENTAL GROUP
110 adults, 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. Blood sample analysis will be performed |
Peripheral venous blood sampling just before lung transplantation, at day 15 and at post-transplantation M1 for lymphocyte phenotyping by cytometry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
T-lymphocytes CD8/HLA-DR+
Time Frame: at day 15 post lung transplantation
|
comparison of the level of T-lymphocytes CD8/HLA-DR+ at day 15 post lung transplantation between recipients who developed acute cellular rejection at 1 month post-transplant and those who not.
|
at day 15 post lung transplantation
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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