T-lymphocytes CD8+/HLA-DR+ and Acute Rejection After Lung Transplantation
NCT ID: NCT03587493
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2018-08-13
2022-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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
BLOOD SAMPLE ANALYSIS
Peripheral venous blood sampling just before lung transplantation, at day 15 and at post-transplantation M1 for lymphocyte phenotyping by cytometry
Interventions
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BLOOD SAMPLE ANALYSIS
Peripheral venous blood sampling just before lung transplantation, at day 15 and at post-transplantation M1 for lymphocyte phenotyping by cytometry
Eligibility Criteria
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Inclusion Criteria
* French national waiting list of lung transplantation
* Transplanted in Marseille or Strasbourg (France)
Exclusion Criteria
* Refused to participate
* Redo lung transplantation
* Other organ transplanted
18 Years
ALL
No
Sponsors
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Vaincre la Mucoviscidose
OTHER
Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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EMILIE GARRIDO PRADALIE
Role: STUDY_DIRECTOR
APHM
Locations
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Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, France
Countries
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Central Contacts
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Facility Contacts
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BENJAMIN COIFFARD, MD
Role: primary
Other Identifiers
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2018-09
Identifier Type: -
Identifier Source: org_study_id