Clinical trial NCT06581549: Immune Microenvironment and Gene Expression Profiling in Mesothelioma
Official title: From Immune Microenvironment Characterization and Gene Expression Profiling to New Drugs Testing in Pleural and Peritoneal Mesothelioma: Imaging-Meso Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mesothelioma
Mesotheliomas Pleural
Mesothelioma; Lung
Keywords: pleura
mesothelioma
PPM patients
lung
Gene expression profiling
Immune microenvironment
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 220 PPM patients will be enrolled in 7 Centers, 150 retrospectively and 70 prospectively.

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

Primary outcomes:
measure: Primary outcome
timeFrame: Through study completion, an average of 3 years
measure: Primary outcome
timeFrame: Through study completion, an average of 3 years
measure: Primary outcome
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Secondary outcome
timeFrame: Through study completion, an average of 3 years
measure: Secondary outcome
timeFrame: Through study completion, an average of 3 years
Other outcomes:
measure: Third outcome
timeFrame: Through study completion, an average of 3 years
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO) IRCCS
state: Pordenone
city: Alessandria
country: Italy
facility: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
city: Bergamo
country: Italy
facility: Asst Papa Giovanni Xxiii Bergamo
city: Genova
country: Italy
facility: Ircss Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda-Milano
city: Milano
country: Italy
facility: Fondazione Ircss Istituto Nazionale Dei Tumori Di Milano
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Parma
country: Italy
facility: Azienda Ospedaliera-Universitaria di Parma
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
Study officials:
affiliation: Istituto Oncologico Veneto IOV IRCCS
name: Giulia Pasello, MD
role: PRINCIPAL_INVESTIGATOR
References: