Active — Not RecruitingNot Applicable

Prediction of Lung Transplant Outcome

France4,200 participantsStarted 2025-06-17

Plain-language 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.

Who can participate

Age range15 Years – 100 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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
✓. Patients understanding the French language
✓. 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
✓. 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

What they're measuring

Discrimination Performance of the Multidimensional Dynamic Prognostic Model for Lung Graft Outcomes, Measured by Area Under the Curve (AUC)

Timeframe: 72 months

Trial details

NCT IDNCT07356752

SponsorHopital Foch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06

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