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Multidimensional Omics and Functional Approaches to Improve Immunotherapy Efficacy in Malignant Pleural Mesothelioma

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria Policlinico Rodolico San Marco di Catania
RECRUITING
Catania
Azienda Ospedaliera Universitaria Luigi Vanvitelli, Napoli
RECRUITING
Naples
Azienda USL IRCCS di Reggio Emilia
RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Contact Information
Primary
Alessia Ciarrocchi, PhD
alessia.ciarrocchi@ausl.re.it
0522/295668
Time Frame
Start Date: 2024-08-30
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 300
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Azienda USL Reggio Emilia - IRCCS

This content was sourced from clinicaltrials.gov