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Recruiting NCT06581549

Immune Microenvironment and Gene Expression Profiling in Mesothelioma

— Observational Mesothelioma Mesotheliomas Pleural Mesothelioma; Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Translation analysis.
Who it may be relevant to
Registry conditions: Mesothelioma, Mesotheliomas Pleural, Mesothelioma; Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

From Immune Microenvironment Characterization and Gene Expression Profiling to New Drugs Testing in Pleural and Peritoneal Mesothelioma: Imaging-Meso Study

Overview

Pleural and peritoneal mesotheliomas (PPM) are rare cancers mostly related to asbestos-exposure, which are characterized by a complex histopathological diagnosis and staging, few therapeutic options and a dismal prognosis. The main unmet medical need in PPM is the lack of a treatment sequence for affected patients. The advent of immune checkpoint inhibitors has changed the first line treatment of PPM, thanks to the improvement in survival achieved by the combination of ipilimumab and nivolumab that are currently approved for non-epithelioid histology in our Country. PPM is characterized by a large heterogeneity of the genomic landscape, which is mainly characterized by the loss of tumour suppressor genes and mutations in DNA repair genes and by an "altered- suppressed" or "excluded" tumor immune microenvironment (TIME). The goal of this project is to improve the immune-biological and molecular stratification of PPM subgroups that can lead to the identification of different personalized treatment approaches. PPM patients (N=220) will be retrospectively (N=150) and prospectively (N=70) recruited from the coordinator center and 6 participating Italian centers. Treatment-naïve tumor samples will be collected and analyzed by bulk gene expression and spatial whole transcriptome analysis, and by 9-color multiplex immunofluorescence. New targets or actionable pathways potentially emerging from such studies will be finally assessed and validated in patient-derived organoids/xenografts that accurately reflect PPM tumorigenesis.

Interventions

  • Other Translation analysis
    Bulk GEP analysis, Spatial whole transcriptome analysis, mIF analysis of tumors

Primary outcome measures

  • Primary outcome [Time frame: Through study completion, an average of 3 years]
  • Primary outcome [Time frame: Through study completion, an average of 3 years]
  • Primary outcome [Time frame: Through study completion, an average of 3 years]
Secondary outcome measures (2)
  • Secondary outcome [Time frame: Through study completion, an average of 3 years]
  • Secondary outcome [Time frame: Through study completion, an average of 3 years]

Eligibility criteria

Inclusion criteria

  • Patients with Mesothelioma of the Pleura and Peritoneum
  • Age greater than 18 years of age
  • Patients undergoing surgery will require both biopsy and surgical sampling material
  • Pathologist's confirmation of the presence of tumor sections in the excised specimens
  • Patients in follow-up from active cancer treatment for at least 6 months

Exclusion criteria

  • Inadequacy of biological material for analysis under study
  • Patients not amenable to active oncologic treatment
  • Patients lost to follow-up before 6 months after the end of active oncologic treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 10 centers
  • Istituto Clinico Humanitas — Rozzano
  • Centro di Riferimento Oncologico (CRO) IRCCS — Aviano
  • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo — Alessandria
  • Asst Papa Giovanni Xxiii Bergamo — Bergamo
  • Ircss Ospedale Policlinico San Martino — Genova
  • Asst Grande Ospedale Metropolitano Niguarda-Milano — Milan
  • Fondazione Ircss Istituto Nazionale Dei Tumori Di Milano — Milan
  • Istituto Oncologico Veneto — Padova
  • … and 2 more centers

Identifiers

NCT: NCT06581549 · Imaging-Meso study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗