About this trial
Malignant pleural mesothelioma (MPM) is a rare and incurable cancer. Most patients are diagnosed with unresectable disease for which treatment options are limited. The lack of prognostic biomarkers further complicates the decision-making. Recently, the introduction of immune checkpoint inhibitors (ICIs) has marked a shift but has failed to produce significant benefits for a large proportion of patients. Maximizing the efficiency of ICIs and developing new protocols to improve drug efficacy is the best possible strategy for improving the life expectancy and quality of life of patients with MPM. This study aims to characterize the organization of the immune system infiltrating mesothelioma and the dynamics of its interaction with the tumor. The rationale is that deciphering this complexity will help improve our understanding of the mechanisms underlying this disease and provide a new tool to optimize the use of ICIs in these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent for participation in the study
Aged > 18 years
Patients with histologically confirmed diagnosis of MPM
Availability of biological material
Disqualifiers
Active current infection
Autoimmune disease
Women in childbearing age not able to exclude pregnancy
Trial population
The study population includes patients diagnosed with Malignant Pleural Mesothelioma (MPM). Both prospective and retrospective cohorts will be included to ensure a comprehensive and biologically representative characterization of the disease. Eligible patients will have histologically confirmed MPM and available tumor biological samples obtained from diagnostic biopsies, surgical resections, or pleural effusions. Samples will include both fresh frozen (FF) material and formalin-fixed paraffin-embedded (FFPE) archival specimens.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
High-resolution mapping of the organization of the tumor-infiltrating immune system in MPM
Characterization of the composition, functional state, and spatial organization of tumor-infiltrating immune cells using integrated bulk, single-cell, and spatial transcriptomic analyses on tumor tissues and malignant pleural effusions.
Secondary outcomes
Immune-related gene signatures by whole transcriptome sequencing (normalized counts).
Immune-phenotyping by multiple parametric cytofluorimetry (cell counts)
Analysis of circulating cytokines by bead-based multiplex assays (concentration micrograms/microliter)
Association between immune features and clinical outcomes by correlation between gene expression (normalized, cell counts and/or concentration counts) and overall survival (months)
Sponsors and contacts
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