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Multidimensional Omics Analysis in Malignant Pleural Mesothelioma (OMIM)

24 апреля 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Злокачественная мезотелиома плевры (MPM)

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

300

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Имя: Alessia Ciarrocchi, PhD
Номер телефона: 0522/295668
Электронная почта: alessia.ciarrocchi@ausl.re.it

Места учебы

Италия
- - Catania, Италия
    - Рекрутинг
    - Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania
    - Контакт:
      
      Giacomo Cusumano, MD PhD
      
      Номер телефона: 095 3781175
      
      Электронная почта: giacomo.cusumano@unict.it
  - Naples, Италия
    - Рекрутинг
    - Azienda Ospedaliera Universitaria Luigi Vanvitelli, Napoli
    - Контакт:
      
      Alfonso Fiorelli, MD PhD
      
      Электронная почта: alfonso.fiorelli@unicampania.it
  - Reggio Emilia, Италия
    - Рекрутинг
    - Azienda USL IRCCS di Reggio Emilia
    - Контакт:
      
      Alessia Ciarrocchi, PhD
      
      Номер телефона: 0522/295668
      
      Электронная почта: alessia.ciarrocchi@ausl.re.it
    - Главный следователь:
      
      Alessia Ciarrocchi, PhD
  - Roma, Италия
    - Рекрутинг
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    - Контакт:
      
      Filippo Lococo, MD
      
      Номер телефона: 06 8881 8881
      
      Электронная почта: filippo.lococo@policlinicogemelli.it

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Взрослый
Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Вероятностная выборка

Исследуемая популяция

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.

Описание

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

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
High-resolution mapping of the organization of the tumor-infiltrating immune system in MPM Временное ограничение: 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

Вторичные показатели результатов

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Azienda USL Reggio Emilia - IRCCS

Следователи

Главный следователь: Alessia Ciarrocchi, Azienda USL - IRCCS di Reggio Emilia

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

30 августа 2024 г.

Первичное завершение (Действительный)

30 августа 2024 г.

Завершение исследования (Оцененный)

28 февраля 2027 г.

Даты регистрации исследования

Первый отправленный

16 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

24 апреля 2026 г.

Первый опубликованный (Действительный)

1 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)