Immune Microenvironment and Gene Expression Profiling in Mesothelioma
NCT ID: NCT06581549
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
220 participants
OBSERVATIONAL
2023-11-02
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Interventions
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Translation analysis
Bulk GEP analysis, Spatial whole transcriptome analysis, mIF analysis of tumors
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients not amenable to active oncologic treatment
* Patients lost to follow-up before 6 months after the end of active oncologic treatment
18 Years
ALL
No
Sponsors
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Istituto Oncologico Veneto IRCCS
OTHER
Responsible Party
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Principal Investigators
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Giulia Pasello, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Oncologico Veneto IOV IRCCS
Locations
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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
Asst Papa Giovanni Xxiii Bergamo
Bergamo, , Italy
Ircss Ospedale Policlinico San Martino
Genova, , Italy
Asst Grande Ospedale Metropolitano Niguarda-Milano
Milan, , Italy
Fondazione Ircss Istituto Nazionale Dei Tumori Di Milano
Milan, , Italy
Istituto Oncologico Veneto
Padua, , Italy
Azienda Ospedaliera-Universitaria di Parma
Parma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Paolo Andrea Zucali, Prof
Role: primary
Alessandro Del Conte, MD
Role: primary
Federica Grosso, MD
Role: primary
Marcello Tiseo, Prof
Role: primary
Other Identifiers
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Imaging-Meso study
Identifier Type: -
Identifier Source: org_study_id
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