Histological Profiles of Lung Allograft Transbronchial Biopsies and Clinical Outcomes After Lung Transplantation

NCT05655208 | Completed

• 1 other identifier: LungCluster
• Study Type: observational
• Target: 498
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lung transplantation is the only curative treatment for individuals with end-stage lung disease. Understanding the lung allograft's histological lesions, which is key for the patient management, remains difficult because of the multiplicity of lesions associated with graft outcome and their interpenetration. The goal of this observational study is to identify clusters of histological lesion on transbronchial biopsies in Lung transplant recipient prospective cohort. The main question\[s\] it aims to answer are:

• what are the different pattern of histological lesion?
• what are the graft outcome associated with the different clusters?

Conditions

Lung Transplant Rejection

Keywords

Lung transplantation; Rejection; Transbronchial biopsy; Donor specific Antibody; Cluster analysis

Outcome Measures

Primary Outcomes (1)

• graft loss resulting in death or re-transplantation and all-cause mortality

  118 months

Secondary Outcomes (1)

• chronic lung allograft dysfunction occurrence

  118 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective cohort included consecutive lung transplant recipients who were transplanted between February 2010 and November 2019 in Foch Hospital and were eligible for inclusion. Every protocol and for cause transbronchial biopsies (TBBs) identified in the Foch hospital database for each patient were analyzed using standardized template. Reports of TBB with one or more missing values were excluded. Protocol TBB were performed after transplantation with the following scheme : month 1 (M1) at 30 ± 10 days, month 2 (M2): 60 ± 10 days, month 3 (M3): 90 ± 10 days, month 4 (M4): 120 ± 10 days, month 6 (M6): 180 ± 10 days, month 9 (M9): 270 ± 10 days and month 12 (M12): 365 ± 10 days. For cause TBB were performed in case of graft dysfunction.

You may qualify if:

• i) age greater than 18 years,
• ii) single or bilateral lung transplantation,
• iii) having at least one transbronchial biopsy available for analysis
• iv) consent their clinical data to be used for research

You may not qualify if:

• Biopsies with at least one missing value in the standardized clinical report were excluded

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead
• Hopital Foch: collaborator

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 19, 2022
• Study Start: February 1, 2010
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF