NCT06581549 Immune Microenvironment and Gene Expression Profiling in Mesothelioma
| NCT ID | NCT06581549 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Oncologico Veneto IRCCS |
| Condition | Mesothelioma |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2023-11-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Giulia Pasello, MD
PRINCIPAL INVESTIGATOR
Istituto Oncologico Veneto IOV IRCCS
Frequently Asked Questions
Who can join the NCT06581549 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mesothelioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06581549 currently recruiting?
Yes, NCT06581549 is actively recruiting participants. Contact the research team at giulia.pasello@iov.veneto.it for enrollment information.
Where is the NCT06581549 trial being conducted?
This trial is being conducted at Rozzano, Italy, Aviano, Italy, Alessandria, Italy, Bergamo, Italy and 6 additional locations.
Who is sponsoring the NCT06581549 clinical trial?
NCT06581549 is sponsored by Istituto Oncologico Veneto IRCCS. The principal investigator is Giulia Pasello, MD at Istituto Oncologico Veneto IOV IRCCS. The trial plans to enroll 220 participants.