What Is MONALISA?
The MONALISA study is a European clinical trial focused on finding a safer, less invasive, and more accurate way to monitor disease recurrence in children with high-risk neuroblastoma. Our goal is to reduce the burden of current disease detection methods and catch signs of relapse earlier, so children can get the care they need sooner.
Why Is MONALISA So Important
- Around 50% of children with high-risk neuroblastoma relapse, even after they appear to be in complete remission and have no evidence of disease.
- Currently, doctors rely on a combination of scans, radioactive imaging, and bone marrow biopsies – often needing anaesthesia – to monitor for relapse.
- These tests can be physically and emotionally challenging for children and distressing for their families, are hard to repeat often, and may not detect very small signs of the disease when it might be more amenable to treatment with innovative new therapies.
- More sensitive, but also less invasive and less toxic monitoring techniques are needed, and these can only be introduced as standard of care following successful clinical evaluation.
- If MONALISA is successful at detecting disease recurrence earlier in patients after they have been treated after relapse, the same techniques can be used to monitor patients after they finish frontline treatment in the future.
What’s Different About MONALISA?
We are testing a new approach called liquid biopsy - a simple blood test that detects small fragments of tumour cell free (cf)DNA and messenger (m)RNA circulating in the bloodstream.
Liquid biopsies are:
- Minimally invasive – only a blood sample is needed
- Sensitive – can detect cancer changes before symptoms appear
- Safe and repeatable – no anaesthesia or radiation
We're also exploring how using liquid biopsies – and the possibility of detecting relapse earlier - could impact the quality of life of children, and the affect on anxiety levels and emotional burden for families and caregivers.
For the first time, Patient-Reported Outcome Measures (PROMs) will be used to capture the impact on children with neuroblastoma and their caregivers.
Study Aims
We’re running a pragmatic randomised clinical trial in 13 hospitals across Europe. Children who have completed treatment for relapsed neuroblastoma are assigned to either:
- Standard monitoring (current methods), or
- Liquid biopsy monitoring
We’re asking:
- Can liquid biopsy detect relapse earlier?
- Does liquid biopsy monitoring affect quality of life for children?
- What is the emotional burden of liquid biopsy monitoring for caregivers?
- How can this technology help doctors make better treatment decisions?
Using a pragmatic randomised clinical trial will provide robust, meaningful evidence on both the clinical effectiveness and the day-to-day impact of liquid biopsy monitoring, helping to shape the future for all children diagnosed with high-risk neuroblastoma.
Supporting Families and Doctors
We’re also developing tools to help families and clinicians:
- A secure digital app to assess and record medical symptoms and emotional distress.
The questionnaires you complete in this app are an essential part of the study and will help us gain valuable insights into how you and your child are doing and to evaluate your and your child's treatment experience. Regardless of the monitoring method, we will ensure that your child receives the best possible care throughout the trial.
- A clinical decision support tool that makes liquid biopsy results easy to understand and use
What This Means for Families
If successful, this project will help make liquid biopsy part of standard care - making disease monitoring:
- Gentler for children
- More precise for care teams
- Better suited to personalised treatment
- An easier and more reassuring approach for families
Learn More or Join the Study
By participating in the MONALISA study and sharing your experiences, you could help shape and improve the future of neuroblastoma care for generations to come.
To find out if your hospital is part of the MONALISA network or to get more information, please contact clinical trial sponsor Prinses Maxima at monalisa@prinsesmaximacentrum.nl.
