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Trajectories of FEV1 After Lung Transplantation (TRAJLUNG)

P

Paris Translational Research Center for Organ Transplantation

Status

Invitation-only

Conditions

Chronic Lung Allograft Dysfunction
Lung Transplant Failure and Rejection

Study type

Observational

Funder types

Other

Identifiers

NCT05934617
TRAJLUNG001

Details and patient eligibility

About

For individuals with ESLD, lung transplantation is the best, or only treatment option with increased pulmonary function and quality of life. The forced expiratory volume in one second (FEV1) is the standard to monitor the lung function after transplantation. The goal of this study is to identify and validate the FEV1 trajectories after lung transplantation, as well as their determinants and outcomes, using an international cohort of lung recipients.

Full description

Chronic lung diseases affect about 500 million individuals and are the third leading cause of death worldwide, accounting for 7% of all mortality. They drive the growing number of individuals with end stage lung disease (ESLD), a public health issue with socioeconomic consequences.

For individuals with ESLD, lung transplantation is the best, or only treatment option with increased pulmonary function and quality of life. Lung recipients remain however particularly at risk, with a median patient survival of around five years, which is much lower than other organ recipients, such as kidney, heart or liver recipients. Adequate monitoring of the lung recipient is therefore crucial to optimize the allograft longevity.

The forced expiratory volume in one second (FEV1) is the standard to monitor the lung function after transplantation, and is used to evaluate the stage and severity of lung allograft diseases. However, according to a literature review we performed, the very few studies that have investigated the FEV1 evolution, and its relationship with outcomes such as death or chronic lung allograft dysfunction, were commonly based on cohort with insufficient data variety and completeness. Importantly, these studies lacked external validation, multidimensional approach, and none has attempted to identify the main profiles of FEV1 trajectories and their associated parameters. As such, the determinants and long-term outcomes of FEV1 trajectories are still poorly understood.

A multidimensional, trajectory-based approach may help unveil clinically relevant organ function profiles among lung recipients. Indeed, several studies have shown the potential existence of underlying trajectories of transplanted organs' function and diseases, and their associations with outcomes and relevance for patient management, such as in kidney or heart transplantation. These studies used a unsupervised approach, which permitted to erase any preconceived clinical ideas. Overall, this approach has shown its value in several medical specialties, in particular in image analysis, oncology, or cardiology.

Therefore, the goal of this study was to identify and validate the FEV1 trajectories after lung transplantation, as well as their determinants and outcomes, using an international cohort of lung recipients, with a protocol-based collection of FEV1 repeated assessments and clinical, biological, histological and immunological data.

Enrollment

2,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Double lung transplant recipients
  • Age 18 years or older at the time of transplant
  • Transplant between January 1, 2010 and December 31, 2020
  • At least 2 PFTs available for analysis

Exclusion criteria

  • Did not consent to clinical data use for research purposes
  • Multi-organ transplant

Trial design

2,500 participants in 12 patient groups

Foch hospital
Description:
Lung recipients from Foch hospital, Suresnes, France
Bichat hospital
Description:
Lung recipients from Bichat hospital, Paris, France
Nantes hospital
Description:
Lung recipients from Nantes hospital, Nantes, France
San Antonio center
Description:
Lung recipients from Pulmonary hypertension center, San Antonio, Texas, US
Marie-Lannelongue hospital
Description:
Lung recipients from Marie-Lannelongue hospital, Le Plessis-Robinson, France
Bordeaux hospital
Description:
Lung recipients from Bordeaux hospital, Nantes, France
Marseille hospital
Description:
Lung recipients from Marseille hospital, Marseille, France
Toulouse hospital
Description:
Lung recipients from Toulouse hospital, Toulouse, France
Strasbourg hospital
Description:
Lung recipients from Strasbourg hospital, Strasbourg, France
Grenoble hospital
Description:
Lung recipients from Grenoble hospital, Grenoble, France
Cochin hospital
Description:
Lung recipients from Strasbourg hospital, Paris, France
Hospital center Mayenne North
Description:
Lung recipients from Hospital center Mayenne North, Mayenne, France

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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