Periodic Reporting for period 1 - MONALISA (A SIOPEN pragmatic clinical trial to MOnitor NeuroblastomA relapse with LIquid biopsy Sensitive Analysis)
Periodo di rendicontazione: 2024-01-01 al 2025-06-30
MONALISA is an international project focused on improving care for children who have been treated for a type of cancer called neuroblastoma. After treatment, more than half of the children with high-risk neuroblastoma may experience a return of the disease (relapse). Thus, neuroblastoma patients that have undergone treatment need to be monitored so that the relapses can be detected as soon as possible. MONALISA aims to detect these relapses earlier than current methods, which could help doctors act sooner and improve the chances of survival.
Currently, doctors usually monitor children with neuroblastoma using scans and bone marrow tests. These methods can be expensive, uncomfortable, and stressful - not just for the child, but also for their families. They often require hospital visits, sedation, or even anaesthesia, which can be tough on young patients and cause side effects. A new type of blood test, called a liquid biopsy, offers a gentler, less invasive, alternative. These are simple blood tests that can pick up tiny traces of cancer-related genetic material (DNA or RNA) in the blood. They are much less invasive, do not require anaesthesia, and can be done more often, making it easier to catch signs of the cancer returning early.
Our research team has already found that these blood tests can often detect a relapse before symptoms appear or before it shows up on a scan. If we can bring this into everyday medical care, it could really change how we look after children with cancer, making the process less painful and more effective. To test this approach, MONALISA will run a clinical study to include 150 patients across 11 countries, comparing the new method with the current standard. If successful, it could lead to earlier diagnosis and better outcomes for children around the world.
MONALISA is the first clinical trial of its kind to test whether liquid biopsies can be used to monitor childhood cancer more effectively. The goal is to make this approach part of everyday care for neuroblastoma and eventually use it as a model for other childhood cancers too. The project also uses digital tools to help doctors make better decisions, and assesses psychological stress of patients and families. By doing this, MONALISA hopes to improve the quality of life for young patients.
Currently, doctors usually monitor children with neuroblastoma using scans and bone marrow tests. These methods can be expensive, uncomfortable, and stressful - not just for the child, but also for their families. They often require hospital visits, sedation, or even anaesthesia, which can be tough on young patients and cause side effects. A new type of blood test, called a liquid biopsy, offers a gentler, less invasive, alternative. These are simple blood tests that can pick up tiny traces of cancer-related genetic material (DNA or RNA) in the blood. They are much less invasive, do not require anaesthesia, and can be done more often, making it easier to catch signs of the cancer returning early.
Our research team has already found that these blood tests can often detect a relapse before symptoms appear or before it shows up on a scan. If we can bring this into everyday medical care, it could really change how we look after children with cancer, making the process less painful and more effective. To test this approach, MONALISA will run a clinical study to include 150 patients across 11 countries, comparing the new method with the current standard. If successful, it could lead to earlier diagnosis and better outcomes for children around the world.
MONALISA is the first clinical trial of its kind to test whether liquid biopsies can be used to monitor childhood cancer more effectively. The goal is to make this approach part of everyday care for neuroblastoma and eventually use it as a model for other childhood cancers too. The project also uses digital tools to help doctors make better decisions, and assesses psychological stress of patients and families. By doing this, MONALISA hopes to improve the quality of life for young patients.
Our primary goal is to test whether liquid biopsies may detect relapse or progression of the disease earlier than with current standard methods. This requires strong interaction between the scientific teams to prepare all partners for the start of the clinical trial. Eleven clinical teams have finalized the clinical trial preparation, and patients will begin to be included in the trial in Autumn 2025. The clinical trial activities also depend on non-clinical partners for their success. As preparatory work before the trial is started, the MONALISA team has achieved the following:
1) Harmonization of the liquid biopsy methods to make sure that all laboratories involved in the project across different countries use the same procedures for the liquid biopsy tests, in accordance with the highest European standards.
2) Development of a new approach to assess patient’s/families’ Quality of Life for the first time in a paediatric oncology trial, including the development of a mobile App for patient/families.
3) Ensuring that all the patient data we collect from both, new and existing sources, can be safely and smoothly connected. This helps us analyse the results more effectively in a new digital tool, while still protecting patients’ privacy.
1) Harmonization of the liquid biopsy methods to make sure that all laboratories involved in the project across different countries use the same procedures for the liquid biopsy tests, in accordance with the highest European standards.
2) Development of a new approach to assess patient’s/families’ Quality of Life for the first time in a paediatric oncology trial, including the development of a mobile App for patient/families.
3) Ensuring that all the patient data we collect from both, new and existing sources, can be safely and smoothly connected. This helps us analyse the results more effectively in a new digital tool, while still protecting patients’ privacy.
One fundamental result so far was the collection and harmonization of liquid biopsy methods and guidelines for the clinical reporting among the MONALISA laboratories that will process samples. This will ensure that all laboratories work according to the same high standards and can report data to the doctors in the same way. Also, the design of a novel digital support tool for doctors considering the doctors’ and patient advocates’ points of view was conducted and the tool will be implemented until the end of 2025. The privacy-preserving infrastructure that supports MONALISA data resulted in a publication (https://ebooks.iospress.nl/doi/10.3233/SHTI250462(si apre in una nuova finestra)) describing the general strategy and establishing the basis for other childhood cancers. In collaboration between clinical psychology experts and the patient advocacy group, MONALISA has launched a multi-lingual patient/family mobile App for tracking the psychological effects of our trial, for the first time in a paediatric study. The App is fully functional and will be used when the clinical trial starts.