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NCT Number: NCT06581549

Immune Microenvironment and Gene Expression Profiling in Mesothelioma

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.

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Key information

Conditions

Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma, Malignant Mesothelioma; Lung Mesotheliomas Pleural Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas, Rozzano, Milano, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Translation analysis

Other

Bulk GEP analysis, Spatial whole transcriptome analysis, mIF analysis of tumors

Primary outcomes

  1. Primary outcome

    Time frame: Through study completion, an average of 3 years

    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.

  2. Primary outcome

    Time frame: Through study completion, an average of 3 years

    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.

  3. Primary outcome

    Time frame: 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 outcomes

  1. Secondary outcome

    Time frame: Through study completion, an average of 3 years

    Characterization and quantification of immune cell distribution and their spatial relationships in treatment naïve tumor samples of PPM patients will be performed by a 9-color multiplex immunofluorescence (mIF) analysis.

  2. Secondary outcome

    Time frame: 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.

Other outcomes

  1. Third outcome

    Time frame: Through study completion, an average of 3 years

    In vitro and in vivo models of PPM for the investigation of activated signatures, new therapeutic targets and drug sensitivity tests. will be performed by:

    • development of in vitro 'organ-like' 3D structures (PDOs) derived from patient tumor tissue;
    • patient-derived xenograft (PDX) from PPM patients;
    • matched comparison of histological and molecular features of PDOs and PDXs with the original tumor tissues;
    • drug sensitivity/resistance tests in vitro and in vivo.

Study contacts

Contact information is provided by the study sponsor or research team.

Gian Luca De Salvo, MD

CONTACT

[email protected]

0498215704

Giulia Pasello, MD

CONTACT

[email protected]

0498215608

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Registry information

Official study title

From Immune Microenvironment Characterization and Gene Expression Profiling to New Drugs Testing in Pleural and Peritoneal Mesothelioma: Imaging-Meso Study

Acronym: Imaging-Meso

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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