Comprehensive molecular and immune profiling for malignant pleural mesothelioma
Official title: Multidimensional Omics and Functional Approaches to Improve Immunotherapy Efficacy in Malignant Pleural Mesothelioma
Run by Azienda USL Reggio Emilia - IRCCS · NCT07561190 · Data updated 2026-11-12
This project will test whether detailed molecular and immune profiling of tumors from adults with malignant pleural mesothelioma can find biomarkers to better guide immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 4 sites (Catania and 3 other locations) |
| Status | Recruiting |
| Started | August 30, 2024 |
| Main results expected | August 30, 2024 |
| Study ends | February 28, 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07561190 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (over 18) with a histologically confirmed diagnosis of malignant pleural mesothelioma who can give informed consent and provide tumor or blood samples—including those eligible for the HITOCH protocol cohort—are the intended participants.
✕Probably not a fit
People with active infections, uncontrolled autoimmune disease, pregnant individuals, or those unable to provide the required biological material are unlikely to benefit from or be eligible for participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project will collect tumor tissue and blood from adults with histologically confirmed malignant pleural mesothelioma at three Italian academic hospitals and apply multidimensional omics (genomics, transcriptomics, proteomics, and immune profiling) to map the tumor-immune ecosystem. High-resolution single-cell and spatial analyses will characterize tumor-infiltrating immune cells and their interactions with cancer cells. Molecular and immune data will be integrated with clinical information to search for prognostic and predictive biomarkers linked to response to immune checkpoint inhibitors and disease course. The ultimate aim is to generate tools that could help optimize the use of immunotherapies and guide future combination approaches.
Why it matters
Potential benefit: If successful, this work could identify biomarkers that help doctors personalize immunotherapy and improve outcomes and quality of life for people with MPM.
How similar studies have gone: Previous immune-profiling and biomarker studies in MPM and other solid tumors have suggested candidate markers but have not produced widely validated predictors, so applying an integrated multidimensional omics approach in MPM is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania
Catania, Italy Recruiting -
Azienda Ospedaliera Universitaria Luigi Vanvitelli, Napoli
Naples, Italy Recruiting -
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Alessia Ciarrocchi — Azienda USL Reggio Emilia - IRCCS
- Study coordinator: Alessia Ciarrocchi, PhD
- Email: alessia.ciarrocchi@ausl.re.it
- Phone: 0522/295668
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.