NCT06637345Recruiting
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 · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 52 (estimated)
- First submitted
- 3 Oct 2024
- Start date
- 15 Mar 2024
- Primary completion date
- 15 Mar 2027
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Diseases
- Mesothelioma, Lung cancer
- NCT number
- NCT06637345
What you commit to
- Study type: Observational
- Planned participants: 52
- From 15 Mar 2024 to the primary completion date, 15 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Disease not histologically established
- Progression pattern not amenable to radiation treatment (ipsilateral or metastatic intrathoracic extensive disease);
Other
- Metastatic patient at diagnosis.
Who the study is looking for
- 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+)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.