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Multidimensional Omics Analysis in Malignant Pleural Mesothelioma (OMIM)

2026년 4월 24일 업데이트: 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.

연구 개요

상태

모병

정황

악성 흉막 중피종(MPM)

상세 설명

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.

연구 유형

관찰

등록 (추정된)

300

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Alessia Ciarrocchi, PhD
전화번호: 0522/295668
이메일: alessia.ciarrocchi@ausl.re.it

연구 장소

이탈리아
- - Catania, 이탈리아
    - 모병
    - Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania
    - 연락하다:
      
      Giacomo Cusumano, MD PhD
      
      전화번호: 095 3781175
      
      이메일: giacomo.cusumano@unict.it
  - Naples, 이탈리아
    - 모병
    - Azienda Ospedaliera Universitaria Luigi Vanvitelli, Napoli
    - 연락하다:
      
      Alfonso Fiorelli, MD PhD
      
      이메일: alfonso.fiorelli@unicampania.it
  - Reggio Emilia, 이탈리아
    - 모병
    - Azienda USL IRCCS di Reggio Emilia
    - 연락하다:
      
      Alessia Ciarrocchi, PhD
      
      전화번호: 0522/295668
      
      이메일: alessia.ciarrocchi@ausl.re.it
    - 수석 연구원:
      
      Alessia Ciarrocchi, PhD
  - Roma, 이탈리아
    - 모병
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    - 연락하다:
      
      Filippo Lococo, MD
      
      전화번호: 06 8881 8881
      
      이메일: filippo.lococo@policlinicogemelli.it

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
High-resolution mapping of the organization of the tumor-infiltrating immune system in MPM 기간: 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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Azienda USL Reggio Emilia - IRCCS

수사관

수석 연구원: Alessia Ciarrocchi, Azienda USL - IRCCS di Reggio Emilia

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 8월 30일

기본 완료 (실제)

2024년 8월 30일

연구 완료 (추정된)

2027년 2월 28일

연구 등록 날짜

최초 제출

2026년 4월 16일

QC 기준을 충족하는 최초 제출

2026년 4월 24일

처음 게시됨 (실제)

2026년 5월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)