Multidimensional Omics Analysis in Malignant Pleural Mesothelioma

NCT07561190 | Recruiting

• 1 other identifier: 357/2024/TESS/IRCCSRE
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

Malignant pleural mesothelioma (MPM) is a rare and incurable cancer. Most patients are diagnosed with unresectable disease for which treatment options are limited. The lack of prognostic biomarkers further complicates the decision-making. Recently, the introduction of immune checkpoint inhibitors (ICIs) has marked a shift but has failed to produce significant benefits for a large proportion of patients. Maximizing the efficiency of ICIs and developing new protocols to improve drug efficacy is the best possible strategy for improving the life expectancy and quality of life of patients with MPM. This study aims to characterize the organization of the immune system infiltrating mesothelioma and the dynamics of its interaction with the tumor. The rationale is that deciphering this complexity will help improve our understanding of the mechanisms underlying this disease and provide a new tool to optimize the use of ICIs in these patients.

Conditions

Malignant Pleural Mesothelioma (MPM)

Keywords

chronic inflammation; biomarkers; immune-related markers; asbestos exposure

Outcome Measures

Primary Outcomes (1)

• High-resolution mapping of the organization of the tumor-infiltrating immune system in MPM

  Characterization of the composition, functional state, and spatial organization of tumor-infiltrating immune cells using integrated bulk, single-cell, and spatial transcriptomic analyses on tumor tissues and malignant pleural effusions.

  36 months

Secondary Outcomes (5)

• Immune-related gene signatures by whole transcriptome sequencing (normalized counts).

  36 months

• Immune-phenotyping by multiple parametric cytofluorimetry (cell counts)

  36 months

• Analysis of circulating cytokines by bead-based multiplex assays (concentration micrograms/microliter)

  36 months

• Association between immune features and clinical outcomes by correlation between gene expression (normalized, cell counts and/or concentration counts) and overall survival (months)

  36 months

• Association between transcriptional signatures and pathological response to chemotherapy by correlation of gene expression (normalized counts) and response to therapy (time to progression -months)

  36 months

Study Arms (3)

C1 - Training set

A prospective cohort of MPM patients enrolled. Analyses will be performed on fresh frozen (FF) tumor samples derived from diagnostic biopsies, surgical resections, or malignant pleural effusions (MPE).

C2 - Validation Set

An independent retrospective cohort of MPM samples collected between 2015 and 2022. This cohort will serve to validate findings obtained in the training set.

C3 - HITHOC Set

An prospective cohort of patients undergoing surgery combined with hyperthermic intrathoracic chemotherapy (HITHOC). This cohort will enable investigation of tumor-immune interactions and treatment response mechanisms in this specific clinical setting.

Eligibility Criteria

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

Study Population

The study population includes patients diagnosed with Malignant Pleural Mesothelioma (MPM). Both prospective and retrospective cohorts will be included to ensure a comprehensive and biologically representative characterization of the disease. Eligible patients will have histologically confirmed MPM and available tumor biological samples obtained from diagnostic biopsies, surgical resections, or pleural effusions. Samples will include both fresh frozen (FF) material and formalin-fixed paraffin-embedded (FFPE) archival specimens.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Aged \> 18 years
• Patients with histologically confirmed diagnosis of MPM
• Availability of biological material
• Clinical indicatio of eligibility for HITOCH protocol (only for C3 cohort)

You may not qualify if:

• Active current infection
• Autoimmune disease
• Women in childbearing age not able to exclude pregnancy

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (4)

Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania

Catania, Italy

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli, Napoli

Naples, Italy

RECRUITING

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; 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

• Alessia Ciarrocchi

  Azienda USL - IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessia Ciarrocchi, PhD

CONTACT

0522/295668; alessia.ciarrocchi@ausl.re.it

Study Design

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

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 1, 2026
• Study Start: August 30, 2024
• Primary Completion: August 30, 2024
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

IT (4)