FibroelastosisNCT05044390
Lung Transplantation for Pleuroparenchymal Fibroelastosis
An observational study of Fibroelastosis, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
This retrospective observational study will evaluate the outcomes of lung transplantation for a rare cause of interstitial lung disease called pleuroparenchymal fibroelastosis. Data will be collected from all transplantation center in France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fibroelastosis
- What is being tested?
- Lung transplantation (single, lobar or bilateral lung transplantation)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Apr 2021to 1 Nov 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with pleuroparenchymal fibroelastosis who underwent lung transplantation in France between 2005 and 2021.
Who may be able to join
- Lung transplantation (any type) for pleuroparenchymal fibroelastosis
- Histologically confirmed pleuroparenchymal fibroelastosis on the recipient lungs
Who cannot join
- All other interstitial lung disease than pleuroparenchymal fibroelastosis
- Pleuroparenchymal fibroelastosis who didn't underwent lung transplantation
Trial locations and contacts
4 sites in 1 country.
France4 sites, 3 recruiting
- Recruiting
Marie Lannelongue Hospital
Le Plessis-Robinson, 92350
: Elie FADEL : Elie FADEL, MD, 33 1 40 94 28 00, e.fadel@ghpsj.fr
- Completed
Hopital Louis Pradel
Lyon
- Recruiting
Bichat Claude Bernard Hospital, APHP
Paris
Pierre MORDANT, MD, + 33 1 40 25 64 40, pierre.mordant@aphp.fr
- Recruiting
Foch Hospital
Suresnes
Edouard SAGE Edouard SAGE, MD, : +33 1 46 25 28 26, e.sage@hopital-foch.fr
About this study
Official title: Lung Transplantation for Pleuroparenchymal Fibroelastosis : a French Multicentric Retrospective Study
This retrospective observational study will evaluate the outcomes of lung transplantation for a rare cause of interstitial lung disease called pleuroparenchymal fibroelastosis. Data will be collected from all transplantation center in France.
- Conditions
- Fibroelastosis
- Being tested
- Lung transplantation (single, lobar or bilateral lung transplantation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung transplantation (single, lobar or bilateral lung transplantation)Procedure or surgery
Lung transplantation were performed for end-stage interstitial lung disease secondary to pleuroparenchymal fibroelastosis
| Study group | Role | What they receive |
|---|---|---|
| lung transplantation | Lung transplantation performed for end-stage interstitial lung disease secondary to pleuroparenchymal fibroelastosis. Receives: Procedure: Lung transplantation (single, lobar or bilateral lung transplantation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative mortality
Any death after lung transplantation during the first 30 days or during the hospitalization following the lung transplantation (in-hospital mortality)
Measured: Any death up to 90 days 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 posted14 Sep 2021
- Study start1 Apr 2021
- Primary completion1 Jul 2021
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibroelastosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044390
- Sponsor's protocol ID
- 420
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clermidy H, Mercier O, Brioude G, Mordant P, Fadel G, Picard C, Chatron E, Le Pavec J, Roux A, Reynaud-Gaubert M, Messika J, Olland A, Demant X, Degot T, Lavrut PM, Jougon J, Sage E, Fadel E, Thomas P, Cottin V, Tronc F. Outcomes of lung transplantation for pleuroparenchymal fibroelastosis: A French multicentric retrospective study. J Heart Lung Transplant. 2024 Oct;43(10):1727-1736. doi: 10.1016/j.healun.2024.06.009. Epub 2024 Jun 21.
PubMed 38909712
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Transplantation for Pleuroparenchymal Fibroelastosis : a French Multicentric Retrospective Study
- ClinicalTrials.gov ID
- NCT05044390
- Acronym / sponsor ID
- 420
- Conditions
- Fibroelastosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 14 Sep 2021 (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.
This retrospective observational study will evaluate the outcomes of lung transplantation for a rare cause of interstitial lung disease called pleuroparenchymal fibroelastosis. Data will be collected from all transplantation center in France.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung transplantation | – | Procedure: Lung transplantation (single, lobar or bilateral lung transplantation)Lung transplantation performed for end-stage interstitial lung disease secondary to pleuroparenchymal fibroelastosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with pleuroparenchymal fibroelastosis who underwent lung transplantation in France between 2005 and 2021.
Key inclusion criteria (2 listed)
- Lung transplantation (any type) for pleuroparenchymal fibroelastosis
- Histologically confirmed pleuroparenchymal fibroelastosis on the recipient lungs
Key exclusion criteria (2 listed)
- All other interstitial lung disease than pleuroparenchymal fibroelastosis
- Pleuroparenchymal fibroelastosis who didn't underwent lung transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung transplantation (single, lobar or bilateral lung transplantation)Lung transplantation were performed for end-stage interstitial lung disease secondary to pleuroparenchymal fibroelastosis | Procedure or surgery | lung transplantation |
Primary outcome
Post-operative mortality
Time frame: Any death up to 90 days after lung transplantation
Any death after lung transplantation during the first 30 days or during the hospitalization following the lung transplantation (in-hospital mortality)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 38909712Clermidy H, Mercier O, Brioude G, Mordant P, Fadel G, Picard C, Chatron E, Le Pavec J, Roux A, Reynaud-Gaubert M, Messika J, Olland A, Demant X, Degot T, Lavrut PM, Jougon J, Sage E, Fadel E, Thomas P, Cottin V, Tronc F. Outcomes of lung transplantation for pleuroparenchymal fibroelastosis: A French multicentric retrospective study. J Heart Lung Transplant. 2024 Oct;43(10):1727-1736. doi: 10.1016/j.healun.2024.06.009. Epub 2024 Jun 21.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibroelastosis, run by Hospices Civils de Lyon at 4 sites 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 2 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 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative mortality (time frame: Any death up to 90 days 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 NCT05044390, which also lists 1 linked publication.
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 14 Sep 2021.