Multidimensional Omics Analysis in Malignant Pleural Mesothelioma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda USL Reggio Emilia - IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Active current infection

Autoimmune disease

Women in childbearing age not able to exclude pregnancy

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 3 trial groups
Group A: C1 - Training set
Group B: C2 - Validation Set
Group C: C3 - HITHOC Set

Trial outcomes

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.

Time frame
36 months

Secondary outcomes

1

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

Time frame
36 months
2

Immune-phenotyping by multiple parametric cytofluorimetry (cell counts)

Time frame
36 months
3

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

Time frame
36 months
4

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

Other outcomes

Sponsors and contacts

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