Proposals should address all of the following:

• Design and conduct innovative investigator-initiated multinational early-stage clinical trials, (phase 1 and 1/2) to accelerate the development of safe, effective, targeted cancer treatments for children and/or adolescents with cancer. Focus should be on cancers with poor prognosis (e.g. with a 5-year overall survival less than 50% from time of diagnosis) at any stage of the disease and for any type. Trials should take into account socio-economic and biological stratification. All data should be disaggregated by sex, gender, age and other relevant variables;
• Develop innovative clinical tools (companion diagnostics) to assess tumour response, tailored to childhood and adolescent cancers, enabling an accurate evaluation of treatment outcomes, monitoring of long-term effects of treatment, and identification of potential risks such as second cancers, thereby improving overall patient care;
• Ultimately, provide scientific evidence to deliver affordable and accessible treatments for children and adolescents with cancer to be implemented by healthcare systems at the level of local communities, European regions, Member States and Associated Countries;
• All datasets produced should be described with metadata records in the EU dataset catalogue of the European Health Data Space, while all tools and models should take advantage of current European research infrastructures, should follow the principles of open science and made available through the future UNCAN.eu platform.

The topic is designed to fill a gap in terms of knowledge, expertise, tools, data and resources in paediatric oncology, to be achieved through multinational, cross-sectoral and multidisciplinary cooperation.

For that purpose, projects should bring together a diverse range of stakeholders and organizations from across Europe and beyond, including academia, data scientists, paediatric oncology centers, hospitals, healthcare practitioners, liquid biopsy companion diagnostics experts, cancer patients and survivors, caregivers, patients and survivors organisations, regulators, and industry etc., to foster collaboration and accelerate the development of innovative cancer treatments and therapeutic approaches including companion diagnostics. Timely contact with regulatory authorities should be foreseen to inform the trial design and feasibility. Use of artificial intelligence tools is encouraged, whenever relevant. Existing resources such as paediatric cancer registries should be appropriately exploited.

This topic requires the effective contribution of Social Science and Humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise in the successful proposal, to produce meaningful and significant effects enhancing the societal impact of the related research activities.