Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581549
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Immune Microenvironment and Gene Expression Profiling in Mesothelioma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
From Immune Microenvironment Characterization and Gene Expression Profiling to New Drugs Testing in Pleural and Peritoneal Mesothelioma Imaging-Meso Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Imaging-Meso
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 N220 will be retrospectively N150 and prospectively N70 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 organoidsxenografts that accurately reflect PPM tumorigenesis
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 N220 will be retrospectively N150 and prospectively N70 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 organoidsxenografts that accurately reflect PPM tumorigenesis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None