Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637345
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy MESORTIBO
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identification of Prognostic and Predictive Biomarkers of Toxicity in Patients With Malignant Pleural Mesothelioma and Treated With High Doses of Radiotherapy MESORTIBO
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MESORTIBO
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 andor markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy
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 andor markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy
Detailed Description:
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 andor markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy
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 andor markers of an immunogenic effect of radiotherapy in the peripheral blood of subjects with malignant pleural mesothelioma for treatment with radical hemithoracic radiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None