Clinical trial · Observational
Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pleural Mesothelioma Malignant | Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Retrospective cohort
- description
- Patients treated with RT with radical intent from 01 January 2014 to the date of study approval
- label
- Prospective cohort
- description
- Patients eligible for radical intent radiotherapy treatment radical, from the date of study approval
Primary outcomes (1)
- measure
- 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
- timeFrame
- up to 36 months
- description
- Differences in fold change of selected biomarkers, between subjects experiencing or not experiencing acute or late toxicity
Secondary outcomes (6)
- measure
- Relation between the severity of radio-induced toxicity and trend of biomarkers associated with it
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Over 18 years of age; * Ability to understand, accept and sign consent informed; * Histological diagnosis of malignant pleural mesothelioma; * Previous administration of chemotherapy; * Previous non-radical surgical approach (diagnostic thoracoscopy or R1-R2 surgery); * Subject eligible for or already treated with RT on hemithorax for radical purposes (50 Gy in fractions on hemithorax + possible boost 60 Gy on residual PET+) Exclusion Criteria: * Disease not histologically established * Progression pattern not amenable to radiation treatment (ipsilateral or metastatic intrathoracic extensive disease); * Metastatic patient at diagnosis.
References
Publications (0)
Data not yet available