Immune Microenvironment and Gene Expression Profiling in Mesothelioma

NCT06581549 | Recruiting

• 1 other identifier: Imaging-Meso study
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 10

Brief Summary

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

Mesothelioma; Mesotheliomas Pleural; Mesothelioma; Lung

Keywords

pleura; mesothelioma; PPM patients; lung; Gene expression profiling; Immune microenvironment

Outcome Measures

Primary Outcomes (3)

• Primary outcome

  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

  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

  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 Outcomes (2)

• Secondary outcome

  Through study completion, an average of 3 years

• Secondary outcome

  Through study completion, an average of 3 years

Other Outcomes (1)

• Third outcome

  Through study completion, an average of 3 years

Interventions

Translation analysis OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (10)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

Centro di Riferimento Oncologico (CRO) IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

RECRUITING

Asst Papa Giovanni Xxiii Bergamo

Bergamo, Italy

RECRUITING

Ircss Ospedale Policlinico San Martino

Genova, Italy

RECRUITING

Asst Grande Ospedale Metropolitano Niguarda-Milano

Milan, Italy

RECRUITING

Fondazione Ircss Istituto Nazionale Dei Tumori Di Milano

Milan, Italy

RECRUITING

Istituto Oncologico Veneto

Padua, 35128, Italy

RECRUITING

Azienda Ospedaliera-Universitaria di Parma

Parma, 43126, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

tumor tissue

MeSH Terms

Conditions

Mesothelioma; Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

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

Study Officials

• Giulia Pasello, MD

  Istituto Oncologico Veneto IOV IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Pasello, MD

CONTACT

0498215608; giulia.pasello@iov.veneto.it

Gian Luca De Salvo, MD

CONTACT

0498215704; clinical.trial@iov.veneto.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: September 3, 2024
• Study Start: November 2, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)