NCT07356752

Prediction of Lung Transplant Outcome

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,200 (estimated)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 15 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Plain Language Summary of the PLUTO Study Prediction of Lung Transplant Outcomes (PLUTO) What is this study about? This study aims to improve how doctors predict the health of lung transplant recipients over time. Many people with severe lung disease need a transplant, but even after receiving a new lung, some still face serious health issues. One of the biggest problems is chronic lung transplant dysfunction (CLAD), which can slowly damage the new lung and is currently irreversible. What is the goal of the study? Researchers want to better understand why some people do worse after a lung transplant. Researchers hope to identify early warning signs and improve diagnosis. The main goal is to build a model that can predict how well a lung transplant will function over time, using routine health data and test results from transplant patients. Who can take part in this study? People aged 15 and older who had a lung transplant between 2009 and 2027 and are being followed at one of the study centers. People who speak French and have national health insurance. People who gave written consent (or whose guardians did, if under 18). The study may also use past data from deceased patients who did not object to research use. How will the study work? The study will follow about 4,200 lung transplant recipients across many centers in France. Researchers will collect clinical data, lung function tests, biopsy results, and blood samples. Researchers will also study new biomarkers (signals in the body that may show how well a transplant is doing) found in blood or lung samples. Using these data, the investigators will build and test tools to predict transplant outcomes. Why is this research important? By understanding early signs of transplant problems, doctors can act sooner and tailor treatment for each person. This may improve long-term survival after a lung transplant and help guide future research. How long is the study? Each participant will be followed for about 3 years, and the full study will last 6 years, including data analysis.

Detailed description

Lung transplantation remains the sole treatment option for thousands of patients with end-stage lung diseases. However, it retains the poorest prognosis of all solid organ transplants. Current challenges include precise, timely identification of different types of rejection episodes, and early identification of risk factors for poor outcomes, particularly chronic lung allograft dysfunction (CLAD), which can take years to develop and is at present irreversible so that preventive strategies are needed. Survival after lung transplantation is limited largely by CLAD, a process by which, through a variety of mechanisms, the patient progressively loses lung function. Early diagnosis of CLAD, and identification of clinical events (such as rejection) which predispose the patient to CLAD, is a key issue in lung transplant research. The investigators aim to assess the trajectories of lung function after transplantation, to identify patterns associated with worse prognosis, and to identify the risk factors of belonging to these trajectories. Then the investigators will propose a dynamic prediction model based on repeated graft evaluation. In addition, the investigators will assess a variety of novel biomarkers, which can be measured in blood, biopsy specimens or bronchoalveolar lavage. These biomarkers will be evaluated in conjunction with the lung function trajectory, baseline known risk factors, and repeated graft evaluation parameters to identify patterns which can define more accurately graft dysfunction, predict poor outcomes at any stage following transplantation, assist clinicians in prognostication for the individual patient, and support the development of future research studies.

Conditions

• Graft Dysfunction
• Lung Transplantation
• Chronic Lung Allograft Dysfunction (CLAD)
• Chronic Rejection of Lung Transplant

Interventions

Type	Name	Description
OTHER	Research Blood Sampling and Biocollection	Blood sampling and biocollection for research purposes, in addition to routine clinical care. Samples include plasma (EDTA tubes), peripheral blood mononuclear cells (CPT tubes), cell-free DNA (Streck tubes), PaxGene tubes and other predefined blood samples collected at clinically indicated time points according to the PLUTO study schedule. When transbronchial biopsies (TBB) are performed for clinical indications, additional tissue fragments are collected for the biocollection. Induced sputum and stool samples may also be collected. These samples are used for biomarker analyses and for the development and validation of multidimensional prognostic models of lung graft function and outcomes.

Timeline

• Start date: 2025-06-17
• Primary completion: 2031-06-01
• Completion: 2031-06-01
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

9 sites across 1 country: France