Lung Transplant Failure and RejectionTRAJLUNGNCT05934617
Trajectories of FEV1 After Lung Transplantation
An observational study of Lung Transplant Failure and Rejection and Chronic Lung Allograft Dysfunction, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Failure and Rejection, Chronic Lung Allograft Dysfunction
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who received a bilateral lung transplantation
Who may be able to join
- 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
Who cannot join
- Did not consent to clinical data use for research purposes
- Multi-organ transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trajectories of FEV1 After Lung Transplantation: Determinants and Clinical Outcomes
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.
Read the detailed 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.
- Keywords
- Lung trajectories, Unsupervised analysis, Determinants of FEV1 trajectories
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Foch hospital | Lung recipients from Foch hospital, Suresnes, France | |
| Bichat hospital | Lung recipients from Bichat hospital, Paris, France | |
| Nantes hospital | Lung recipients from Nantes hospital, Nantes, France | |
| San Antonio center | Lung recipients from Pulmonary hypertension center, San Antonio, Texas, US | |
| Marie-Lannelongue hospital | Lung recipients from Marie-Lannelongue hospital, Le Plessis-Robinson, France | |
| Bordeaux hospital | Lung recipients from Bordeaux hospital, Nantes, France | |
| Marseille hospital | Lung recipients from Marseille hospital, Marseille, France | |
| Toulouse hospital | Lung recipients from Toulouse hospital, Toulouse, France | |
| Strasbourg hospital | Lung recipients from Strasbourg hospital, Strasbourg, France | |
| Grenoble hospital | Lung recipients from Grenoble hospital, Grenoble, France | |
| Cochin hospital | Lung recipients from Strasbourg hospital, Paris, France | |
| Hospital center Mayenne North | Lung recipients from Hospital center Mayenne North, Mayenne, France |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 trajectories
FEV1 trajectories of the lung recipient
Measured: Up to 10 years after lung transplantation
Secondary outcomes (3)
Patient death
Patient death after lung transplantation
Measured: Up to 10 years after lung transplantation
Allograft failure
Allograft failure after lung transplantation
Measured: Up to 10 years after lung transplantation
Chronic lung allograft dysfunction
CLAD after lung transplantation
Measured: Up to 10 years after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant Failure and RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Roux, MD, PhD, Principal investigator, Foch hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934617
- Sponsor's protocol ID
- TRAJLUNG001
- Acronym
- TRAJLUNG
- Status last verified
- May 2024
- First submitted
- 28 Jun 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data may be shared for research purpose upon reasonable request.
Publications
GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.
PubMed 32526187Li X, Cao X, Guo M, Xie M, Liu X. Trends and risk factors of mortality and disability adjusted life years for chronic respiratory diseases from 1990 to 2017: systematic analysis for the Global Burden of Disease Study 2017. BMJ. 2020 Feb 19;368:m234. doi: 10.1136/bmj.m234.
PubMed 32075787Brakema EA, Tabyshova A, van der Kleij RMJJ, Sooronbaev T, Lionis C, Anastasaki M, An PL, Nguyen LT, Kirenga B, Walusimbi S, Postma MJ, Chavannes NH, van Boven JFM; FRESH AIR collaborators. The socioeconomic burden of chronic lung disease in low-resource settings across the globe - an observational FRESH AIR study. Respir Res. 2019 Dec 21;20(1):291. doi: 10.1186/s12931-019-1255-z.
PubMed 31864411Perch M, Hayes D Jr, Cherikh WS, Zuckermann A, Harhay MO, Hsich E, Potena L, Sadavarte A, Lindblad K, Singh TP, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-ninth adult lung transplantation report-2022; focus on lung transplant recipients with chronic obstructive pulmonary disease. J Heart Lung Transplant. 2022 Oct;41(10):1335-1347. doi: 10.1016/j.healun.2022.08.007. Epub 2022 Aug 20. No abstract available.
PubMed 36050206
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectories of FEV1 After Lung Transplantation: Determinants and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT05934617
- Acronym / sponsor ID
- TRAJLUNG / TRAJLUNG001
- Keywords
- Lung trajectories, Unsupervised analysis, Determinants of FEV1 trajectories
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Foch hospital | – | –Lung recipients from Foch hospital, Suresnes, France |
| Bichat hospital | – | –Lung recipients from Bichat hospital, Paris, France |
| Nantes hospital | – | –Lung recipients from Nantes hospital, Nantes, France |
| San Antonio center | – | –Lung recipients from Pulmonary hypertension center, San Antonio, Texas, US |
| Marie-Lannelongue hospital | – | –Lung recipients from Marie-Lannelongue hospital, Le Plessis-Robinson, France |
| Bordeaux hospital | – | –Lung recipients from Bordeaux hospital, Nantes, France |
| Marseille hospital | – | –Lung recipients from Marseille hospital, Marseille, France |
| Toulouse hospital | – | –Lung recipients from Toulouse hospital, Toulouse, France |
| Strasbourg hospital | – | –Lung recipients from Strasbourg hospital, Strasbourg, France |
| Grenoble hospital | – | –Lung recipients from Grenoble hospital, Grenoble, France |
| Cochin hospital | – | –Lung recipients from Strasbourg hospital, Paris, France |
| Hospital center Mayenne North | – | –Lung recipients from Hospital center Mayenne North, Mayenne, France |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who received a bilateral lung transplantation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Did not consent to clinical data use for research purposes
- Multi-organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FEV1 trajectories
Time frame: Up to 10 years after lung transplantation
FEV1 trajectories of the lung recipient
3 secondary outcomes
Patient death
Time frame: Up to 10 years after lung transplantation
Allograft failure
Time frame: Up to 10 years after lung transplantation
Chronic lung allograft dysfunction
Time frame: Up to 10 years after lung transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Background: PubMed 32526187GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.
- Background: PubMed 32075787Li X, Cao X, Guo M, Xie M, Liu X. Trends and risk factors of mortality and disability adjusted life years for chronic respiratory diseases from 1990 to 2017: systematic analysis for the Global Burden of Disease Study 2017. BMJ. 2020 Feb 19;368:m234. doi: 10.1136/bmj.m234.
- Background: PubMed 31864411Brakema EA, Tabyshova A, van der Kleij RMJJ, Sooronbaev T, Lionis C, Anastasaki M, An PL, Nguyen LT, Kirenga B, Walusimbi S, Postma MJ, Chavannes NH, van Boven JFM; FRESH AIR collaborators. The socioeconomic burden of chronic lung disease in low-resource settings across the globe - an observational FRESH AIR study. Respir Res. 2019 Dec 21;20(1):291. doi: 10.1186/s12931-019-1255-z.
- Background: PubMed 36050206Perch M, Hayes D Jr, Cherikh WS, Zuckermann A, Harhay MO, Hsich E, Potena L, Sadavarte A, Lindblad K, Singh TP, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-ninth adult lung transplantation report-2022; focus on lung transplant recipients with chronic obstructive pulmonary disease. J Heart Lung Transplant. 2022 Oct;41(10):1335-1347. doi: 10.1016/j.healun.2022.08.007. Epub 2022 Aug 20. No abstract available.
- Individual participant dataSharing planned: Yes. Deidentified data may be shared for research purpose upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Roux, MD, PhD principal investigator
Foch hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Failure and Rejection and Chronic Lung Allograft Dysfunction, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 trajectories (time frame: Up to 10 years after lung transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05934617, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.