Multidimensional Omics Analysis in Malignant Pleural Mesothelioma (OMIM)
24. dubna 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Odhadovaný)
300
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Alessia Ciarrocchi, PhD
- Telefonní číslo: 0522/295668
- E-mail: alessia.ciarrocchi@ausl.re.it
Studijní místa
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Catania, Itálie
- Nábor
- Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania
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Kontakt:
- Giacomo Cusumano, MD PhD
- Telefonní číslo: 095 3781175
- E-mail: giacomo.cusumano@unict.it
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Naples, Itálie
- Nábor
- 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, Itálie
- Nábor
- Azienda USL IRCCS Di Reggio Emilia
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Kontakt:
- Alessia Ciarrocchi, PhD
- Telefonní číslo: 0522/295668
- E-mail: alessia.ciarrocchi@ausl.re.it
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Vrchní vyšetřovatel:
- Alessia Ciarrocchi, PhD
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Roma, Itálie
- Nábor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Kontakt:
- Filippo Lococo, MD
- Telefonní číslo: 06 8881 8881
- E-mail: filippo.lococo@policlinicogemelli.it
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
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.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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High-resolution mapping of the organization of the tumor-infiltrating immune system in MPM
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Immune-related gene signatures by whole transcriptome sequencing (normalized counts).
Časové okno: 36 months
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36 months
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Immune-phenotyping by multiple parametric cytofluorimetry (cell counts)
Časové okno: 36 months
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36 months
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Analysis of circulating cytokines by bead-based multiplex assays (concentration micrograms/microliter)
Časové okno: 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)
Časové okno: 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)
Časové okno: 36 months
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36 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Alessia Ciarrocchi, Azienda USL - IRCCS di Reggio Emilia
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
30. srpna 2024
Primární dokončení (Aktuální)
30. srpna 2024
Dokončení studie (Odhadovaný)
28. února 2027
Termíny zápisu do studia
První předloženo
16. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
24. dubna 2026
První zveřejněno (Aktuální)
1. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. dubna 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 357/2024/TESS/IRCCSRE
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