Immune Microenvironment and Gene Expression Profiling in Mesothelioma
- Conditions
- MesotheliomaMesotheliomas PleuralMesothelioma; Lung
- Registration Number
- NCT06581549
- Lead Sponsor
- Istituto Oncologico Veneto IRCCS
- Brief Summary
Pleural and peritoneal mesotheliomas (PPM) are rare cancers mostly related to asbestos-exposure, which are characterized by a complex histopathological diagnosis and staging, few therapeutic options and a dismal prognosis. The main unmet medical need in PPM is the lack of a treatment sequence for affected patients. The advent of immune checkpoint inhibitors has changed the first line treatment of PPM, thanks to the improvement in survival achieved by the combination of ipilimumab and nivolumab that are currently approved for non-epithelioid histology in our Country.
PPM is characterized by a large heterogeneity of the genomic landscape, which is mainly characterized by the loss of tumour suppressor genes and mutations in DNA repair genes and by an "altered- suppressed" or "excluded" tumor immune microenvironment (TIME).
The goal of this project is to improve the immune-biological and molecular stratification of PPM subgroups that can lead to the identification of different personalized treatment approaches. PPM patients (N=220) will be retrospectively (N=150) and prospectively (N=70) recruited from the coordinator center and 6 participating Italian centers. Treatment-naïve tumor samples will be collected and analyzed by bulk gene expression and spatial whole transcriptome analysis, and by 9-color multiplex immunofluorescence.
New targets or actionable pathways potentially emerging from such studies will be finally assessed and validated in patient-derived organoids/xenografts that accurately reflect PPM tumorigenesis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
- Patients with Mesothelioma of the Pleura and Peritoneum
- Age greater than 18 years of age
- Patients undergoing surgery will require both biopsy and surgical sampling material
- Pathologist's confirmation of the presence of tumor sections in the excised specimens
- Patients in follow-up from active cancer treatment for at least 6 months
- Inadequacy of biological material for analysis under study
- Patients not amenable to active oncologic treatment
- Patients lost to follow-up before 6 months after the end of active oncologic treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome Through study completion, an average of 3 years PPM surgical specimens and comparison with GEP in matched treatment-naïve tumor samples will be performed by gene expression profile analysis with GEP analysis.
- Secondary Outcome Measures
Name Time Method Secondary outcome Through study completion, an average of 3 years Immune phenotypes defined by mIF and the immune signatures identified by GEP analyses will be performed in each treatment-naïve tumor sample.
Trial Locations
- Locations (13)
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Centro di Riferimento Oncologico (CRO) IRCCS
🇮🇹Aviano, Pordenone, Italy
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Azienda Ospedaliero Universitaria Delle Marche
🇮🇹Ancona, Italy
Asst Grande Ospedale Metropolitano Niguarda-Milano
🇮🇹Milano, Italy
Istituto Clinico Humanitas Gavazzeni
🇮🇹Bergamo, Italy
Azienda Ospedaliero Universitaria di Ferrara
🇮🇹Ferrara, Italy
Asst Papa Giovanni Xxiii Bergamo
🇮🇹Bergamo, Italy
Ircss Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Fondazione Ircss Istituto Nazionale Dei Tumori Di Milano
🇮🇹Milano, Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
Azienda Ospedaliera-Universitaria di Parma
🇮🇹Parma, Italy
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy