An observational study in Pleural Mesothelioma Malignant, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Centro di Riferimento Oncologico - Aviano · Observational
Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage.
In other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly due to immunogenic effects attributed to high doses of RT and ICIs-mediated activation of anti-tumour T lymphocytes.
Both treatments, RT and immunotherapy, have demonstrated a survival advantage in MPM, but are associated with non-negligible pulmonary toxicity. Therefore, the combination of these 2 therapeutic approaches requires a careful assessment of risk factors for the occurrence of toxicity. The identification of circulating biomarkers capable of predicting the onset of severe toxicity induced by radical radiation treatment is an important clinical need in MPM.
This study aims to monitor circulating biomarkers, such as molecules involved in inflammation and oxidative stress and cellular effectors modulated by radiation treatment and potentially associated with the development of toxicity and/or markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy.
Malignant pleural mesothelioma (MPM) is a tumour that originates from the pleural layers (visceral and parietal) that envelop the lungs and the inner wall of the thoracic cage.
In other tumour contexts, numerous studies have demonstrated a synergistic effect between RT and Immune Checkpoint Inhibitors (ICIs), mainly due to immunogenic effects attributed to high doses of RT and ICIs-mediated activation of anti-tumour T lymphocytes.
Both treatments, RT and immunotherapy, have demonstrated a survival advantage in MPM, but are associated with non-negligible pulmonary toxicity. Therefore, the combination of these 2 therapeutic approaches requires a careful assessment of risk factors for the occurrence of toxicity. The identification of circulating biomarkers capable of predicting the onset of severe toxicity induced by radical radiation treatment is an important clinical need in MPM.
This study aims to monitor circulating biomarkers, such as molecules involved in inflammation and oxidative stress and cellular effectors modulated by radiation treatment and potentially associated with the development of toxicity and/or markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy.
418 studies on the registry are indexed under Mesothelioma, Malignant; 73 are open to participants now.
This study's planned enrollment of 52 is below the median of 119 across 50 observational studies indexed under Mesothelioma, Malignant.
Browse Mesothelioma, Malignant studies →Centro di Riferimento Oncologico - Aviano is the lead sponsor of 50 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with non-metastatic MPM previously treated with chemotherapy, undergoing a non-radical long-sparing surgical approach and treated with RT with radical intent (retrospective cohort) or eligible for RT with radical intent (prospective cohort)
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Exclusion Criteria:
Patients treated with RT with radical intent from 01 January 2014 to the date of study approval
Patients eligible for radical intent radiotherapy treatment radical, from the date of study approval
Association between biomarker levels measured at the end of radiation treatment and pulmonary toxicity of grade ≥2 associated with RT developed as an acute (within 6 months) or late (after 6 months) event
Differences in fold change of selected biomarkers, between subjects experiencing or not experiencing acute or late toxicity
Time frame: up to 36 months
Relation between the severity of radio-induced toxicity and trend of biomarkers associated with it
Evaluation of linear trend of biomarkers fold change in relation with toxicity severity
Time frame: up to 36 months
Identifying biomarkers associated with lung toxicity potentially predictive of pulmonary fibrosis
Difference in frequencies of selected biomarkers between subgroups of patients with or without pulmonary fibrosis
Time frame: up to 36 months
Identifying signs of radio-induced immunomodulation among significant changes induced by hemithoracic radical radiotherapy in analysed biomarkers
difference in median values of selected biomarkers before and after treatment
Time frame: up to 36 months
Association between the levels of biomarkers measured at the end of treatment radiation and overall survival (OS) at 24 months
Relation between overall survival and levels of biomarkers fold change using Cox regression. OS will be defined as time from beginning of the therapy until death from any cause or end of follow-up, whichever comes first.
Time frame: 24 moths after end of treatment
To assess the prognostic potential of basal levels of analysed biomarkers
Relation between OS and pretreatment levels of selected biomarkers. Levels of biomarkers will be dichotomized based on pretreatment median value. Kaplan-Meier method and log rank test will be used. OS will be defined as time from beginning of the therapy until death from any cause or end of follow-up, whichever comes first.
Time frame: up to 36 months
Association between the levels of biomarkers variation (between baseline and treatment end) and Progression Free Survival (PFS) at 12 months
Relation between PFS and levels of biomarkers fold change compared to pre-treatment value. PFS will be defined as time from beginning of the therapy until objective PD, death or end of follow-up, whichever comes first.
Time frame: 12 months after end of treatment
Started Mar 2024 (actual). Primary completion is estimated for Mar 2027, 36 months after the start.
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Centro di Riferimento Oncologico - Aviano