Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation

Study Overview
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Brief Summary
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Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation. Each dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample.

Official Title
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Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation

Conditions
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Lung Transplant Rejection, Lung Transplant Failure, Lung Transplant; Complications, Lung Transplant Failure and Rejection

Intervention / Treatment
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* Other: Collection of biological samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women over 15 years of age Suffering from a lung condition requiring a transplant planned at Foch Hospital or being followed up at Foch Hospital following a lung transplant Have signed the informed consent form and for patients aged 15 to 18 years that the person(s) exercising parental authority has/have signed the informed consent. Be affiliated with a Health Insurance plan. Exclusion Criteria: Pregnant, parturient and/or lactating woman Hemoglobin level less than or equal to 8g/dl Persons of full age who are subject to a legal protection measure or who are unable to express their consent Persons under the protection of justice Not being able to follow the study requirements for geographical, social or psychological reasons Patient refusal.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with lung disease requiring transplantation or who have undergone lung transplantation<br>There is no intervention to be administered. | Other: Collection of biological samples<br>* Blood sample, biopsies sample, hair sample.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers). | Correlation between blood biomarkers (cell free DNA, Donor Specific Antibodies characterization) and graft rejection. | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression). | Correlation of biomarkers (graft) with the functionality of the allograft | 15 years | 
| Stratify lung transplant recipients using non-invasive biomarkers and a gene expression profile for risk of allograft loss based on first year post-transplant data | Assessment of the risk of graft loss based on biomarker variations in repeated measurements. | 15 years | 
| Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection | Correlation between gene expression in lung transplants and response to treatment of rejection | 15 years | 
| Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection. | Costs incurred to define the risk of allograft rejection | 15 years | 
| Assessing patient acceptability and well-being using invasive and non-invasive biomarkers | Variation in patient well-being with the use of a non-invasive strategy to define the risk of allograft rejection | 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DATACOL