Multidimensional Omics Analysis in Malignant Pleural Mesothelioma (OMIM)

April 24, 2026 updated by: Azienda USL Reggio Emilia - IRCCS

Multidimensional Omics and Functional Approaches to Improve Immunotherapy Efficacy in Malignant Pleural Mesothelioma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Malignant Pleural Mesothelioma (MPM) is a rare and highly aggressive malignancy characterized by poor prognosis and limited therapeutic options. Most patients are diagnosed at an advanced, unresectable stage, with a median overall survival of approximately one year. Although the introduction of immune checkpoint inhibitors (ICIs) has represented a significant advancement, a substantial proportion of patients fail to derive meaningful clinical benefit. The lack of reliable prognostic and predictive biomarkers, together with marked molecular heterogeneity and limited understanding of disease biology, significantly hampers the development of effective therapeutic strategies. MPM is strongly associated with chronic inflammation driven by asbestos exposure, which profoundly alters the pleural microenvironment. Within this context, tumor cells and immune cells engage in dynamic and reciprocal interactions, generating a complex ecosystem that promotes disease progression and the emergence of aggressive phenotypes. The ability of tumor cells to modulate immune system activity is considered a key driver of MPM pathogenesis. This study aims to comprehensively characterize the organization of the tumor-infiltrating immune system and the dynamic interactions between tumor and immune cells. To achieve this goal, an integrative and multidimensional omics approach will be employed to generate a high-resolution map of MPM ecosystem and to identify novel biomarkers and potential therapeutic targets. This is an exploratory, non-interventional, non-pharmacological study with both prospective and retrospective components, conducted exclusively on biological samples collected during routine clinical practice. The study population will be structured into three complementary cohorts. A training prospective cohort (C1 - Training Set) including newly diagnosed MPM patients from whom fresh frozen (FF) tumor samples will be collected from diagnostic biopsies, surgical resections, or malignant pleural effusions, enabling in-depth characterization of the tumor and immune microenvironment. A validation independent retrospective cohort (C2 - Validation Set) including MPM samples collected between 2015 and 2022 and used to validate findings obtained in the training cohort. A nested cohort within C1 (C3 - HITHOC Set) that will include patients undergoing surgery combined with hyperthermic intrathoracic chemotherapy (HITHOC), allowing investigation of tumor-immune interactions and treatment response mechanisms in this specific clinical setting. By integrating data across these three cohorts, the study aims to identify immune-related markers associated with tumor aggressiveness, discover novel targets for next-generation immunotherapies, and characterize mechanisms underlying response to chemotherapy, with particular focus on the HITHOC setting. Expected outcomes include improved understanding of MPM biology, identification of novel biomarkers, and optimization of immunotherapy strategies, ultimately contributing to the development of more effective and personalized treatments for patients affected by this disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania
        • Contact:
      • Naples, Italy
      • Reggio Emilia, Italy
        • Recruiting
        • Azienda USL IRCCS di Reggio Emilia
        • Contact:
        • Principal Investigator:
          • Alessia Ciarrocchi, PhD
      • Roma, Italy

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
High-resolution mapping of the organization of the tumor-infiltrating immune system in MPM
Time Frame: 36 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Immune-related gene signatures by whole transcriptome sequencing (normalized counts).
Time Frame: 36 months
36 months
Immune-phenotyping by multiple parametric cytofluorimetry (cell counts)
Time Frame: 36 months
36 months
Analysis of circulating cytokines by bead-based multiplex assays (concentration micrograms/microliter)
Time Frame: 36 months
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)
Time Frame: 36 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)
Time Frame: 36 months
36 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda USL Reggio Emilia - IRCCS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alessia Ciarrocchi, Azienda USL - IRCCS di Reggio Emilia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 357/2024/TESS/IRCCSRE

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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