MesotheliomaImaging-MesoNCT06581549
Immune Microenvironment and Gene Expression Profiling in Mesothelioma
An observational study of Mesothelioma and Mesotheliomas Pleural, run by Istituto Oncologico Veneto IRCCS at 10 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Mesotheliomas Pleural, Mesothelioma; Lung
- What is being tested?
- Translation analysis
- How many people
- 125 participants
- Where
- 10 sitesItaly
- Study dates
- 2 Nov 2023to 5 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 220 PPM patients will be enrolled in 7 Centers, 150 retrospectively and 70 prospectively.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Centro di Riferimento Oncologico (CRO) IRCCS
Aviano, Pordenone, 33081
Asst Papa Giovanni Xxiii Bergamo
Bergamo
Ircss Ospedale Policlinico San Martino
Genova
Asst Grande Ospedale Metropolitano Niguarda-Milano
Milan
Fondazione Ircss Istituto Nazionale Dei Tumori Di Milano
Milan
Istituto Oncologico Veneto
Padova, 35128
Azienda Ospedaliera-Universitaria di Parma
Parma, 43126
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Azienda Ospedaliera Universitaria Integrata Verona
Verona
About this study
Official title: From Immune Microenvironment Characterization and Gene Expression Profiling to New Drugs Testing in Pleural and Peritoneal Mesothelioma: Imaging-Meso Study
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).
Read more
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.
- Conditions
- Mesothelioma, Mesotheliomas Pleural, Mesothelioma; Lung
- Being tested
- Translation analysis
- Keywords
- pleura, mesothelioma, PPM patients, lung, Gene expression profiling, Immune microenvironment
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translation analysisOther
Bulk GEP analysis, Spatial whole transcriptome analysis, mIF analysis of tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
PPM treatment-naïve tumor samples and classification in different clusters according to the differential expression of molecular and gene signatures by Gene expression profile (GEP) analysis.
Measured: Through study completion, an average of 3 years
Primary outcome
Identification of molecular and immune signatures predictive of resistance or sensitivity to systemic anticancer drugs: chemotherapy or immunotherapy administered as first line treatment by spatial whole transcriptome analysis.
Measured: Through study completion, an average of 3 years
Primary outcome
PPM surgical specimens and comparison with GEP in matched treatment-naïve tumor samples will be performed by gene expression profile analysis with GEP analysis.
Measured: Through study completion, an average of 3 years
Secondary outcomes (2)
Secondary outcome
Characterization and quantification of immune cell distribution and their spatial relationships in treatment naïve tumor samples of PPM patients will be performed by a 9-color multiplex immunofluorescence (mIF) analysis.
Measured: Through study completion, an average of 3 years
Secondary outcome
Immune phenotypes defined by mIF and the immune signatures identified by GEP analyses will be performed in each treatment-naïve tumor sample.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start2 Nov 2023
- Primary completion5 Aug 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulia Pasello, MD, Principal investigator, Istituto Oncologico Veneto IOV IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581549
- Sponsor's protocol ID
- Imaging-Meso study
- Acronym
- Imaging-Meso
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Immune Microenvironment Characterization and Gene Expression Profiling to New Drugs Testing in Pleural and Peritoneal Mesothelioma: Imaging-Meso Study
- ClinicalTrials.gov ID
- NCT06581549
- Acronym / sponsor ID
- Imaging-Meso / Imaging-Meso study
- Conditions
- Mesothelioma, Mesotheliomas Pleural, Mesothelioma; Lung
- Keywords
- pleura, mesothelioma, PPM patients, lung, Gene expression profiling, Immune microenvironment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 220 PPM patients will be enrolled in 7 Centers, 150 retrospectively and 70 prospectively.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translation analysisBulk GEP analysis, Spatial whole transcriptome analysis, mIF analysis of tumors | Other | – |
Primary outcome
Primary outcome
Time frame: Through study completion, an average of 3 years
PPM treatment-naïve tumor samples and classification in different clusters according to the differential expression of molecular and gene signatures by Gene expression profile (GEP) analysis.
Primary outcome
Time frame: Through study completion, an average of 3 years
Identification of molecular and immune signatures predictive of resistance or sensitivity to systemic anticancer drugs: chemotherapy or immunotherapy administered as first line treatment by spatial whole transcriptome analysis.
Primary outcome
Time frame: Through study completion, an average of 3 years
PPM surgical specimens and comparison with GEP in matched treatment-naïve tumor samples will be performed by gene expression profile analysis with GEP analysis.
2 secondary outcomes
Secondary outcome
Time frame: Through study completion, an average of 3 years
Secondary outcome
Time frame: Through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulia Pasello, MD principal investigator
Istituto Oncologico Veneto IOV IRCCS
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mesothelioma and Mesotheliomas Pleural, run by Istituto Oncologico Veneto IRCCS at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: Through study completion, an average of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.