Multidimensional Omics Analysis in Malignant Pleural Mesothelioma (OMIM)
2026年4月24日 更新者：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.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
観察的
入学 (推定)
300
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Alessia Ciarrocchi, PhD
- 電話番号：0522/295668
- メール：alessia.ciarrocchi@ausl.re.it
研究場所
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Catania、イタリア
- 募集
- Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania
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コンタクト：
- Giacomo Cusumano, MD PhD
- 電話番号：095 3781175
- メール：giacomo.cusumano@unict.it
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Naples、イタリア
- 募集
- Azienda Ospedaliera Universitaria Luigi Vanvitelli, Napoli
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コンタクト：
- Alfonso Fiorelli, MD PhD
- メール：alfonso.fiorelli@unicampania.it
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Reggio Emilia、イタリア
- 募集
- Azienda USL IRCCS di Reggio Emilia
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コンタクト：
- Alessia Ciarrocchi, PhD
- 電話番号：0522/295668
- メール：alessia.ciarrocchi@ausl.re.it
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主任研究者：
- Alessia Ciarrocchi, PhD
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Roma、イタリア
- 募集
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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コンタクト：
- Filippo Lococo, MD
- 電話番号：06 8881 8881
- メール：filippo.lococo@policlinicogemelli.it
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
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.
|
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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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
High-resolution mapping of the organization of the tumor-infiltrating immune system in MPM
時間枠：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
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Immune-related gene signatures by whole transcriptome sequencing (normalized counts).
時間枠：36 months
|
36 months
|
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Immune-phenotyping by multiple parametric cytofluorimetry (cell counts)
時間枠：36 months
|
36 months
|
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Analysis of circulating cytokines by bead-based multiplex assays (concentration micrograms/microliter)
時間枠：36 months
|
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)
時間枠：36 months
|
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)
時間枠：36 months
|
36 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Alessia Ciarrocchi、Azienda USL - IRCCS di Reggio Emilia
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年8月30日
一次修了 (実際)
2024年8月30日
研究の完了 (推定)
2027年2月28日
試験登録日
最初に提出
2026年4月16日
QC基準を満たした最初の提出物
2026年4月24日
最初の投稿 (実際)
2026年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月1日
QC基準を満たした最後の更新が送信されました
2026年4月24日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。