NCT06637345 Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy (MESORTIBO)
| NCT ID | NCT06637345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro di Riferimento Oncologico - Aviano |
| Condition | Pleural Mesothelioma Malignant |
| Study Type | OBSERVATIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 52 participants in total. It began in 2024-03-15 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Alberto Revelant, MD
PRINCIPAL INVESTIGATOR
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Frequently Asked Questions
Who can join the NCT06637345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Mesothelioma Malignant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06637345 currently recruiting?
Yes, NCT06637345 is actively recruiting participants. Contact the research team at alberto.revelant@cro.it for enrollment information.
Where is the NCT06637345 trial being conducted?
This trial is being conducted at Aviano, Italy.
Who is sponsoring the NCT06637345 clinical trial?
NCT06637345 is sponsored by Centro di Riferimento Oncologico - Aviano. The principal investigator is Alberto Revelant, MD at Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS. The trial plans to enroll 52 participants.