Immune Microenvironment and Gene Expression Profiling in Mesothelioma (Imaging-Meso)

September 4, 2025 updated by: Istituto Oncologico Veneto IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
        • Contact:
          • Federica Grosso, MD
      • Bergamo, Italy
        • Recruiting
        • ASST Papa Giovanni XXIII Bergamo
        • Contact:
      • Genova, Italy
      • Milan, Italy
      • Milan, Italy
      • Padua, Italy, 35128
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliera-Universitaria di Parma
        • Contact:
          • Marcello Tiseo, Prof
      • Verona, Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
          • Paolo Andrea Zucali, Prof
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Recruiting
        • Centro di Riferimento Oncologico (CRO) IRCCS
        • Contact:
          • Alessandro Del Conte, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

220 PPM patients will be enrolled in 7 Centers, 150 retrospectively and 70 prospectively.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 years
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.
Through study completion, an average of 3 years
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.
Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 years
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.
Through study completion, an average of 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Oncologico Veneto IRCCS

Investigators

  • Principal Investigator: Giulia Pasello, MD, Istituto Oncologico Veneto IOV IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 29, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Imaging-Meso study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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