protocolSection identificationModule nctId: NCT06302556, orgStudyIdInfo id: 2022XJ9W4F, secondaryIdInfos id: G53D2300526 0006, type: OTHER_GRANT, domain: Ministry of University and Research. NextGenetationUE, briefTitle: The Role of Immune Checkpoints in Lung Transplant (ILTRA), acronym: ILTRA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, collaborators name: University of Milan, collaborators name: University of Padova, collaborators name: University of Turin, Italy, descriptionModule briefSummary: 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., conditionsModule conditions: Lung Transplant Rejection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Immune checkpoints analysis, interventions name: Gene expression analysis, outcomesModule primaryOutcomes measure: Lung-tissue immune-checkpoint profile and bronchoalveolar immune-cells mRNA signature in acute rejection after lung transplantation., primaryOutcomes measure: Lung-tissue immune-checkpoint profile in chronic rejection after lung transplantation., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, city: Milan, zip: 20122, country: Italy, contacts name: Mario Nosotti, Medicine, role: CONTACT, phone: 3393924679, email: mario.nosotti@unimi.it, contacts name: Ilaria Righi, Medicine, role: CONTACT, phone: +393470556707, email: ilaria.righi78@gmail.com, contacts name: Mario Nosotti, Medicine, role: PRINCIPAL_INVESTIGATOR, contacts name: Ilaria Righi, Medicine, role: SUB_INVESTIGATOR, contacts name: Lorenzo Rosso, Medicine, role: SUB_INVESTIGATOR, contacts name: Valentina Vaira, Biology, role: SUB_INVESTIGATOR, contacts name: Mario Clerici, Medicine, role: SUB_INVESTIGATOR, contacts name: Daria Trabattoni, Biology, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: University of Modena and Reggio Emilia, city: Modena, zip: 41121, country: Italy, contacts name: Marcello Pinti, Biology, role: CONTACT, phone: +390592055386, email: marcello.pinti@unimore.it, geoPoint lat: 44.64783, lon: 10.92539, locations facility: University of Padua, city: Padova, zip: 35131, country: Italy, contacts name: Marco Schiavon, Medicine, role: CONTACT, phone: +39 3475642901, email: marco.schiavon@unipd.it, geoPoint lat: 45.40797, lon: 11.88586, locations facility: University of Turin, city: Torino, zip: 10124, country: Italy, contacts name: Massimo Boffini, Medicine, role: CONTACT, phone: +39 3474267034, email: massimo.boffini@unito.it, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False