Comprehensive molecular and immune profiling for malignant pleural mesothelioma
Multidimensional Omics and Functional Approaches to Improve Immunotherapy Efficacy in Malignant Pleural Mesothelioma
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 4 sites (Catania and 3 other locations) |
| Trial ID | NCT07561190 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Catania and 3 other locations
- 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 - IRCCS di Reggio Emilia
- Study coordinator: Alessia Ciarrocchi, PhD
- Email: alessia.ciarrocchi@ausl.re.it
- Phone: 0522/295668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.