Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05655208 |
Other study ID # |
LungCluster |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 1, 2010 |
Est. completion date |
November 30, 2019 |
Study information
Verified date |
March 2023 |
Source |
Paris Translational Research Center for Organ Transplantation |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Lung transplantation is the only curative treatment for individuals with end-stage lung
disease. Understanding the lung allograft's histological lesions, which is key for the
patient management, remains difficult because of the multiplicity of lesions associated with
graft outcome and their interpenetration.
The goal of this observational study is to identify clusters of histological lesion on
transbronchial biopsies in Lung transplant recipient prospective cohort.
The main question[s] it aims to answer are:
- what are the different pattern of histological lesion?
- what are the graft outcome associated with the different clusters?
Description:
SCIENTIFIC JUSTIFICATION:
With more than three million deaths per year, the chronic obstructive pulmonary disease is
currently the third cause of mortality worldwide , and contributes to the growing number of
individuals with end-stage lung disease, which is now a major issue for world public health.
Overall, for individuals with end-stage lung disease, lung transplantation (LTx) is the only
treatment able to increase patient survival and quality of life, with more than 4,500 lung
transplantations performed each year.
Despite major progresses made in the last decade regarding organ preservation, procurement
and short term outcome little improvements have been made on the histological
characterization of rejection, which remains the main determinant of patient death after lung
transplantation.
One of the main limitation of histological analysis is the multiplicity of lesions associated
with graft outcome and their interpenetration. Historically, the perivascular infiltrate or
cellular rejection (A lesions), and the lymphocytic bronchiolitis (B lesions) are the first
histological lesions associated with graft dysfunction and stand as key parameters in patient
management. In addition to A and B lesions, a wide spectrum of histological lesions of the
lung allograft is associated with clinical outcomes.
However, to our best knowledge, only few studies thoroughly investigated the various
elementary lesions in the broad scope of histological analysis, and their association with
clinical outcomes. Although informative, those studies usually suffer from a small number of
patients, convenience clinical samples from registry, and the lack of innovative statistical
approach. Overall, the wide spectrum of the allograft lesions has not been investigated using
a large number of transbronchial biopsies with standardized protocol and biopsy reading, and
a multidimensional approach on deeply phenotyped data.
The recent use of unsupervised method in organ transplantation has permitted the
identification of clinically relevant patient clusters and may be a relevant strategy to
decipher the heterogeneity in histological lesions in lung recipients.
Therefore, using a deeply phenotyped prospective cohort of lung recipients and consecutive
transbronchial biopsies with protocolized evaluation and interpretation covering the
different cases scenario encountered in clinical practice, the investigators aim to identify
histological clusters based on histological lesions and assess their associations with graft
and patient outcomes.
OBJECTIVES:
Main objective: To identify of histological cluster of lung allograft Transbronchial biopsies
Secondary objective: To evaluate association of each cluster with baseline clinical data and
anti HLA donor specific antibody and graft outcome
INTERVENTIONS:
This is an observational study that involves only minimal risk and constraints. The
intervention consists in the evaluation of parameters measured as part of the standard of
care at the time of post-transplant allograft biopsy.
No medicinal product is under investigation in this protocol.
EXPECTED BENEFITS for the participants and for society:
There will be no immediate individual benefit for the patient to participate in the study.
This study will provide us with data of Lung transplant patients that may allow the
improvement of clinical decisions and the long-term lung allograft management.
MINIMAL RISKS AND CONSTRAINTS added by the study No additional intervention beyond the
standard of care will be performed in this study.
RECRUITING CENTER:
- Single center study
- Hopital Foch, Suresnes, France