- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05044390
Lung Transplantation for Pleuroparenchymal Fibroelastosis
September 6, 2021 updated by: Hospices Civils de Lyon
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Le Plessis-Robinson, France, 92350
- Recruiting
- Marie Lannelongue Hospital
-
Contact:
- : Elie FADEL : Elie FADEL, MD
- Phone Number: 33 1 40 94 28 00
- Email: e.fadel@ghpsj.fr
-
Lyon, France
- Completed
- Hôpital Louis Pradel
-
Paris, France
- Recruiting
- Bichat Claude Bernard Hospital, APHP
-
Contact:
- Pierre MORDANT, MD
- Phone Number: + 33 1 40 25 64 40
- Email: pierre.mordant@aphp.fr
-
Suresnes, France
- Recruiting
- Foch Hospital
-
Contact:
- Edouard SAGE Edouard SAGE, MD
- Phone Number: : +33 1 46 25 28 26
- Email: e.sage@hopital-foch.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with pleuroparenchymal fibroelastosis who underwent lung transplantation in France between 2005 and 2021.
Description
Inclusion Criteria:
- Lung transplantation (any type) for pleuroparenchymal fibroelastosis
- Histologically confirmed pleuroparenchymal fibroelastosis on the recipient lungs
Exclusion Criteria:
- All other interstitial lung disease than pleuroparenchymal fibroelastosis
- Pleuroparenchymal fibroelastosis who didn't underwent lung transplantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
lung transplantation
Lung transplantation performed for end-stage interstitial lung disease secondary to pleuroparenchymal fibroelastosis.
|
Lung transplantation were performed for end-stage interstitial lung disease secondary to pleuroparenchymal fibroelastosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Any death up to 90 days after lung transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
July 1, 2021
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
August 30, 2021
First Submitted That Met QC Criteria
September 6, 2021
First Posted (Actual)
September 14, 2021
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 6, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 420
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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