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Multidimensional Omics Analysis in Malignant Pleural Mesothelioma (OMIM)

24. april 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
      • Catania, Italien
        • Rekruttering
        • Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania
        • Kontakt:
      • Naples, Italien
      • Reggio Emilia, Italien
        • Rekruttering
        • Azienda USL IRCCS Di Reggio Emilia
        • Kontakt:
        • Ledende efterforsker:
          • Alessia Ciarrocchi, PhD
      • Roma, Italien

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
High-resolution mapping of the organization of the tumor-infiltrating immune system in MPM
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
Immune-related gene signatures by whole transcriptome sequencing (normalized counts).
Tidsramme: 36 months
36 months
Immune-phenotyping by multiple parametric cytofluorimetry (cell counts)
Tidsramme: 36 months
36 months
Analysis of circulating cytokines by bead-based multiplex assays (concentration micrograms/microliter)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 36 months
36 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Efterforskere

  • Ledende efterforsker: Alessia Ciarrocchi, Azienda USL - IRCCS di Reggio Emilia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. august 2024

Primær færdiggørelse (Faktiske)

30. august 2024

Studieafslutning (Anslået)

28. februar 2027

Datoer for studieregistrering

Først indsendt

16. april 2026

Først indsendt, der opfyldte QC-kriterier

24. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 357/2024/TESS/IRCCSRE

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Malignt Pleural Mesotheliom (MPM)

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