High-risk neuroblastoma accounts for 15% of cancer-related deaths in children. Half of the patients diagnosed with neuroblastoma in the EU have high-risk disease and recurrences occur frequently. In these children, conventional therapies are no longer effective. Monitoring for disease relapse and therapy response is crucial for the survival chance of these patients. The current standard of care for monitoring relies on imaging technologies and bone marrow assessment, which are costly, invasive and a burden for children and their families. More sensitive, less invasive and less toxic monitoring techniques are needed in neuroblastoma. Liquid biopsy is a suitable alternative technique because it is minimally invasive, allows frequent sampling and can sensitively detect tumor molecular markers in the blood.
Under the scientific lead of St. Anna Children's Cancer Research Institute (St. Anna CCRI) and Princess Máxima Center for Pediatric Oncology (MAXIMA), MONALISA is conducting a pragmatic clinical trial to evaluate the use of liquid biopsies as a monitoring tool for relapsed neuroblastoma. Since May 2026, CCRI has assumed the role of project coordinator while continuing to provide the scientific leadership of the project together with PMC. As part of the project, we will test if liquid biopsies can detect relapse events earlier than the standard of care and consequently avoid unnecessary diagnostic procedures. This approach will also help to personalize treatment options and may prevent both over- and under-treatment. Ultimately, the goal is to improve the quality of life of affected children by enabling earlier accurate tumor detection and hopefully better overall survival through more targeted treatment interventions.
MONALISA will set the basis to establish liquid biopsies as standard-of-care to monitor relapsed neuroblastoma, as a blueprint for other pediatric cancers.
The project is built on the long-standing collaboration of the SIOPEN network and its members. From the launch of MONALISA in 2024 until May 2026, SIOPE served as the project coordinator, supporting the consortium through the first half of the project. In May 2026, coordination was transferred to St. Anna CCRI, marking the next phase of MONALISA’s journey.
Project Objectives
- Monitor patients with relapsed neuroblastoma
- Reliable assessment of early molecular progression or relapse
- Establish a pragmatic randomized clinical trial
- Develop a digital decision support tool to help oncologists use the new monitoring
- Assess patient-reported outcomes and quality of life
Expected Outcomes and Impact
- Reduced time to relapse detection
- Improved overall survival of patients with neuroblastoma
- Change in care strategy
- Improve quality of life
- Increased acceptance among oncologists, patients and parents
- Accelerate digital transformation of research innovation
- Knowledge dissemination
- Reduced healthcare costs
