Multidimensional Omics Analysis in Malignant Pleural Mesothelioma (OMIM)
24. April 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
300
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Alessia Ciarrocchi, PhD
- Telefonnummer: 0522/295668
- E-Mail: alessia.ciarrocchi@ausl.re.it
Studienorte
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Catania, Italien
- Rekrutierung
- Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania
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Kontakt:
- Giacomo Cusumano, MD PhD
- Telefonnummer: 095 3781175
- E-Mail: giacomo.cusumano@unict.it
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Naples, Italien
- Rekrutierung
- Azienda Ospedaliera Universitaria Luigi Vanvitelli, Napoli
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Kontakt:
- Alfonso Fiorelli, MD PhD
- E-Mail: alfonso.fiorelli@unicampania.it
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Reggio Emilia, Italien
- Rekrutierung
- Azienda USL IRCCS Di Reggio Emilia
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Kontakt:
- Alessia Ciarrocchi, PhD
- Telefonnummer: 0522/295668
- E-Mail: alessia.ciarrocchi@ausl.re.it
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Hauptermittler:
- Alessia Ciarrocchi, PhD
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Roma, Italien
- Rekrutierung
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Kontakt:
- Filippo Lococo, MD
- Telefonnummer: 06 8881 8881
- E-Mail: filippo.lococo@policlinicogemelli.it
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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).
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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High-resolution mapping of the organization of the tumor-infiltrating immune system in MPM
Zeitfenster: 36 months
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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.
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36 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Immune-related gene signatures by whole transcriptome sequencing (normalized counts).
Zeitfenster: 36 months
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36 months
|
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Immune-phenotyping by multiple parametric cytofluorimetry (cell counts)
Zeitfenster: 36 months
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36 months
|
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Analysis of circulating cytokines by bead-based multiplex assays (concentration micrograms/microliter)
Zeitfenster: 36 months
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36 months
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Association between immune features and clinical outcomes by correlation between gene expression (normalized, cell counts and/or concentration counts) and overall survival (months)
Zeitfenster: 36 months
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36 months
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Association between transcriptional signatures and pathological response to chemotherapy by correlation of gene expression (normalized counts) and response to therapy (time to progression -months)
Zeitfenster: 36 months
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36 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Alessia Ciarrocchi, Azienda USL - IRCCS di Reggio Emilia
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
30. August 2024
Primärer Abschluss (Tatsächlich)
30. August 2024
Studienabschluss (Geschätzt)
28. Februar 2027
Studienanmeldedaten
Zuerst eingereicht
16. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. April 2026
Zuerst gepostet (Tatsächlich)
1. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 357/2024/TESS/IRCCSRE
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