Observational Not yet recruiting
NCT06302556 on ClinicalTrials.gov
The Role of Immune Checkpoints in Lung Transplant (ILTRA)
Official title: The Role of Immune Checkpoints in Lung Transplant: the Pathways of Rejection and the Immunomodulatory Therapeutic Perspectives
- Sponsor: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Collaborators: University of Milan, University of Padova, University of Turin, Italy
- Enrollment: 280 (Estimated)
- Study start: 2024-04-01 (Estimated)
- Primary completion: 2026-01-01 (Estimated)
- Study completion: 2026-02-01 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
Brief Summary
The goal of this observational study is to learn about rejection in lung transplantation.
The main question it aims to answer is:
• what is the role of immune checkpoints in lung transplantation? Participants will describe pathways of rejection in lung transplantation analyzing the immune checkpoints on explanted lungs as well as trans-bronchial biopsies.
Conditions
- Lung Transplant Rejection
Intervention / Treatment
- Diagnostic Test: Immune checkpoints analysis
- Diagnostic Test: Gene expression analysis
Primary Outcome Measures
-
Lung-tissue immune-checkpoint profile and bronchoalveolar immune-cells mRNA signature in acute rejection after lung transplantation.
(Twelve months after lung transplantation (prospective data))
Prevalence of immune checkpoint markers and gene-expression on leukocytes from transbronchial biopsies and bronchoalveolar lavage. Participants: cohort number 3. -
Lung-tissue immune-checkpoint profile in chronic rejection after lung transplantation.
(Cohort 1: at re-transplantation for chronic lung allograft dysfunction (cross-sectional data). Cohort 2: from one to 36 months after lung transplantation (retrospective data))
Prevalence of immune checkpoint markers on leukocytes from explanted lung grafts and transbronchial biopsies. Participants: cohort number 1 and 2.
Countries
Italy
Locations and Investigators
-
Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy
- Mario Nosotti, Medicine
- Ilaria Righi, Medicine
- Mario Nosotti, Medicine (Principal Investigator)
- Ilaria Righi, Medicine
- Lorenzo Rosso, Medicine
- Valentina Vaira, Biology
- Mario Clerici, Medicine
- Daria Trabattoni, Biology
-
University of Modena and Reggio Emilia, Modena, Italy
- Marcello Pinti, Biology
-
University of Padua, Padova, Italy
- Marco Schiavon, Medicine
-
University of Turin, Torino, Italy
- Massimo Boffini, Medicine
Study Officials
- Mario Nosotti, Medicine (Principal Investigator) — University of Milan, Italy