Prediction of Lung Transplant Outcome (PLUTO)

Hopital Foch

Status: Active, not recruiting

Conditions: Graft Dysfunction; Chronic Rejection of Lung Transplant; Lung Transplantation; Chronic Lung Allograft Dysfunction (CLAD)

Treatments: Other: Research Blood Sampling and Biocollection

Study type: Interventional

Funder types: Other

Identifiers

NCT07356752

2023_0104

ID RCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,200 estimated patients

Sex: All

Ages: 15 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 15 and over transplanted (first or re transplantation, single, bilateral or combined) between 01/01/2009 and the date of the first prospective inclusion, benefiting from regular monitoring in one of the participating centers
2. Or Newly transplanted patient single, bilateral LTx, combined LTx) aged of 15 or more at the moment of transplantation, in one of the participating centers between the date of the first prospective inclusion during three years
3. Patients understanding the French language
4. Having signed an informed consent form for this study*, and for patients aged 15 to 18 that the holder(s) of parental authority has signed the informed consent
5. Being covered by a national health insurance * Already transplanted patient deceased before the beginning of the study: only clinical data (including biological samples clinically indicated likely to be reused, like serum of transbronchial biopsy (tbb)) will be included under condition of tracing any refusal, reluctance, reservations to the use of data, in patient files, by text analysis in all available digital documents. This approach allows both an exhaustive analysis in a timely, rapid way, that human reading would not allow. In case of mention of refusal, reluctance, reservations, the patient's data will not be collected.

Exclusion criteria

1. Hemoglobin levels inferior than or equal to 8g/dl
2. Patients not understanding the French language
3. Don't being covered by a national health insurance
4. Being under guardianship or curatorship
5. Pregnant women* * Candidate for LTx are not allowed for pregnancy. During the follow up, pregnancies are permitted subject to medical approval of the project and close monitoring. It was decided that during pregnancy the participation for biocollection, would be suspended temporally. Realistically 1/ in the former situation patient candidate for Lung transplantation are not pregnant, 2/ in contrast long after transplantation, medically supervised pregnancy could occur. In that case, research sampling might be suspended temporarily.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,200 participants in 1 patient group

patients who have been transplanted or retransplanted and who are followed-up

Other group

Description:

Patients aged 15 and over transplanted (first or re transplantation, single, bilateral or combined) between 01/01/2009 and the date of the first prospective inclusion, benefiting from regular monitoring in one of the participating center. * Newly transplanted patient single, bilateral LTx, combined LTx) aged of 15 or more at the moment of transplantation, in one of the participating center between the date of the first prospective inclusion in during three years * Deceased patients before the beginning of the study, transplanted between 01/01/2009 and the date of the first prospective inclusion, who have not objected to the reuse of their health data.

Treatment:

Other: Research Blood Sampling and Biocollection