T-lymphocytes CD8+/HLA-DR+ and Acute Rejection After Lung Transplantation

NCT03587493 | Unknown

• 1 other identifier: 2018-09
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transplant Failure

Outcome Measures

Primary Outcomes (1)

• T-lymphocytes CD8/HLA-DR+

  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

Study Arms (1)

EXPERIMENTAL GROUP

EXPERIMENTAL

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

Other: BLOOD SAMPLE ANALYSIS

Interventions

BLOOD SAMPLE ANALYSIS OTHER

Peripheral venous blood sampling just before lung transplantation, at day 15 and at post-transplantation M1 for lymphocyte phenotyping by cytometry

EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• French national waiting list of lung transplantation
• Transplanted in Marseille or Strasbourg (France)

You may not qualify if:

• \<18 years old
• Refused to participate
• Redo lung transplantation
• Other organ transplanted

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead
• Vaincre la Mucoviscidose: collaborator

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

RECRUITING

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

BENJAMIN COIFFARD, MD

CONTACT

+33 491964355; Benjamin.COIFFARD@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: August 13, 2018
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

FR (1)