Clinical trial · Observational
Immune Microenvironment and Gene Expression Profiling in Mesothelioma
From Immune Microenvironment Characterization and Gene Expression Profiling to New Drugs Testing in Pleural and Peritoneal Mesothelioma: Imaging-Meso Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Mesothelioma; Lung | — | UNRESOLVED | — |
| Mesotheliomas Pleural | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Translation analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Primary outcome
- timeFrame
- Through study completion, an average of 3 years
- description
- PPM treatment-naïve tumor samples and classification in different clusters according to the differential expression of molecular and gene signatures by Gene expression profile (GEP) analysis.
- measure
- Primary outcome
- timeFrame
- Through study completion, an average of 3 years
- description
- Identification of molecular and immune signatures predictive of resistance or sensitivity to systemic anticancer drugs: chemotherapy or immunotherapy administered as first line treatment by spatial whole transcriptome analysis.
- measure
- Primary outcome
- timeFrame
- Through study completion, an average of 3 years
- description
- PPM surgical specimens and comparison with GEP in matched treatment-naïve tumor samples will be performed by gene expression profile analysis with GEP analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available