Deliverables

This policy brief summarises recommendations from the third “Understanding (Risk Factors & Determinants)” cluster meeting to strengthen cancer prevention, early detection and equity access in the context of the EU Cancer Mission. It calls for support on interoperable, FAIR-by-design cancer data ecosystems that connect project-level resources with national cancer data nodes and emerging European hubs such as EUCAIM, UNCAN and CANDLE, ensuring sustainable reuse of legacy and new datasets. The report urges EU policymakers to prioritise integrated risk-stratification tools and minimally invasive biomarkers, backed by trustworthy AI, federated analytics and shared quality standards to accelerate translation into screening, surveillance, and personalised care. It further recommends that EU-level action on cancer inequalities adopt a broader perspective, including prevention, diagnostics, treatment and survivorship, while systematically embedding patient and citizen voices and clear governance frameworks for digital health and AI. Finally, the brief proposes that the European Commission and Member States should use these suggestions to guide future legislation, funding programmes, and mission-oriented initiatives, ensuring that scientific advances are matched by equitable access and long-term infrastructure support.

This document summarises the discussions and conclusions as presented by the participating projects. It does not introduce new content. This document reports on the third annual meeting of the Horizon Europe “Understanding (Risk Factors & Determinants)” cluster, hosted by the MELCAYA project in Barcelona the 15th of October 2025. It brought together the five cluster projects (GENIAL, LUCIA, ELMUMY, DISCERN and MELCAYA) focused on how risk factors and health determinants drive cancer development and progression. The first part of the meeting reviewed collaborative work on FAIR data management convergence on healthcare data standards and plans for long-term interoperability with emerging EU infrastructures such as UNCAN and EUCAIM. Scientific sessions showcased cross-project results on genetic susceptibility, exposome, omics and functional models, as risk stratification and early diagnosis tools, including AI-based models, smart sensors and proteomic signatures.

Further sessions addressed health policy implementation, inequalities and citizen engagement, highlighting gaps in rare cancers, the value of patient-generated evidence and methods such as social labs and Delphi surveys to co-create recommendations. The meeting concluded with presentations from UNCAN-Connect, CANDLE and EUCAIM projects, outlining how new federated European cancer data hubs will provide sustainable, secure environments for reusing cluster data and models. Overall, the cluster is progressing towards integrated, policy-relevant evidence and interoperable infrastructures that support the EU Missions on Cancer.

This deliverable has been conceived in the frame of T4.3 “General population screening”, T4.4 “Diagnosis and precision follow-up and stratification” and T4.5 “Contextual-empirical investigations to evaluate the realization of identified values”. These tasks are devoted to the recruitment of a prospective cohort of around 3,000 volunteers that will be followed up for 2 years and on the diagnosis, including Indeterminate Pulmonary Nodules (IPN) characterization, with an accentuation on the Never Smokers and Reduced Smokers (NSRS) patients, incorporating Breath Analyser (BAN), Wide-biomarker-spectrum Multi-Use Sensing Patch (WBSP) and spectrometry-on-card (SPOC) into clinical studies.

Regarding Task 4.5, it examines whether identified socio-technical values (in WP1-3) (e.g., transparency, bias, accountability, explanability) are realized when the technology is used. To achieve this goal, the different contexts of the use of technology are to be analysed as different contextual variables come into play to impact the way values are understood.

Volunteers have been recruited from different clinical centers (“Servicio Andaluz de Salud” (SAS) and “Osakidetza Servicio Vasco de Salud” (OSA), in Spain; “Centre Hospitalier Universitaire de Liège” (CHUL) in Belgium, and “Centre for Tuberculosis and Lung Diseases (CTLD) of Riga East University Hospital (REUH)” in Latvia). Non-invasive devices such as Breath Analyzer (BAN), Multiomics (MO) and spectrometry-on-card (SPOC) are monitoring these participants.

The entire study cohort is currently being followed up. For 2 years, participants of the study will attend to 4 visits: baseline, month 6, month 12 and month 24. During these visits, the following tests and procedures will be carried out:

– Baseline visit: blood test, spirometry, lifestyle questionnaires, sociodemographic data, medical record data, exposure to harmful agents data, physical exploration, LDCT scan and new lung cancer screening devices testing (breath analyzer and spectrometry-on-card)
– 6 months visit: remote visit where sociodemographic data, medical record data and exposure to harmful agents data will be recorded.
– 12 months visit: spirometry, lifestyle questionnaires, sociodemographic data, medical record data, exposure to harmful agents’ data and physical exploration.
– 24 months visit: spirometry, ifestyle questionnaires, sociodemographic data, medical record data, exposure to harmful agents’ data, physical exploration, low-dose computed tomography (LDCT) scan and new lung cancer screening devices testing (breath analyzer and spectrometry-on-card).

(See the following of the Executive Summary in file).

This report provides a summary of the conclusions from the second annual meeting of the “Understanding (risk factors & determinants)” cluster within the EU Cancer Mission. The morning sessions featured scientific updates from each project, while the afternoon focused on “Cancer Mission Data Initiatives”, presented by a European Commission policy officer, and discussions on topics outlined in the common work plan deliverable. Key points included the importance of data management, AI in cancer research, risk stratification tools, and best practices in healthcare policy implementation. The meeting underscored the importance of collaborative efforts in addressing cancer research challenges and highlighted future plans for enhancing data sharing, citizen engagement, and addressing inequalities in cancer care.

This report summarizes the Policy brief formulating recommendations based on the research and innovation strand of the “Understanding” annual cluster meeting -Y2. The goal of this deliverable is to provide an annual policy brief with recommendations on Research & Innovation (R&I) on the macro scale, i.e., from the perspective of the “Understanding (risk factors & determinants)” cluster. This policy brief formulates recommendations to foster collaboration, focusing on data/material management, technological advancmeents, risk factor analysis, and policy implementation, based on the research and innovation strand of the “Understanding” annual cluster meeting in the second year. This deliverable raises common barriers and potential recommendations as well as practical recommendations for the near future.

This document presents (1) a summary of the design and development of the design and development of the LUCIA project website and related technical requirements, and (2) an overview of the website sections. D6.5 will be delivered on time while the website will go live in July 2023 as per European Commission PO approval. While it contains only essential information about the project, the LUCIA objectives and preliminary plans; the content will grow as the 4-year project unfolds.

The deliverable “Communication, Dissemination and Exploitation Plan” (due Month 6 [M6]) will provide the strategic framework for content development.

This report summarises the Policy brief formulating recommendations based on the research and innovation strand of the “Understanding” annual cluster meeting, M12. The goal of this deliverable is to provide an annual policy brief with recommendations on R&I on the macro scale, i.e., from the perspective of “Understanding (risk factors and determinants) cluster.

This policy brief formulates recommendations to foster collaboration, focusing on data/material management, technological advancements, risk factor analysis, and policy implementation, based on the research and innovation strand of the “Understanding” annual cluster meeting, M12. This deliverable raises common barriers and potential recommendations as well as practical recommendations for the near future.

This deliverable has been conceived in the frame of T4.2 “Clinical protocols and requirements”, which is devolted to the organization of the assessment methodology that will be implemented during the development of each use-case at different levels after risk stratification of citizens and clinical scenario. All the designs will be based on the feedback and results after of tasks developed in WP3 and WP5. The following actions will be deployed:

– developing and agreeing on the sampling plan;
– choosing and testing measurement instruments;
– choosing the early diagnosis clinical pathways;
– choosing the diagnosis workflow; and
– planning the data collection and the validation protocols.

After the protocol design (which has already been finalized), all the authorizations required by the regulatory authorities will be obtained.

This deliverable provides the essential regulatory and research documents for the beginning and development of Task 4.3: “General population screening” under which the prospective clinical study will start recruiting participants and gathering data for the LUCIA project.

The content of this deliverable summarizes the clinical protocol for the cohort study in the general population screening and the regulatory authorizations that must be obtained before the enrollment of the first participant in the study.

This deliverable includes the following information:

– Final version of the study protocols of each clinical site as sent to each one of their respective ethics committees.
– Regulatory authorizations required for the enrolment of the first study participant.

The consortium partners have finalized and agreed on the common prospective clinical protocol, which ensures we reach the highest standards of quality and clinical and scientific relevance. The protocols have already been submitted to each one of the Ethics Committees for its approval request in December 2023.

We foresee to obtain the approval of the Ethics Committees in the coming months and start the recruitment of the volunteers that will participate in the prospective clinical study as soon as we get those approvals.

Since the approval has not been obtained yet, we provide in this document the documents of Request for Evaluation of research projects by the Ethics Committees of each clinical site until we obtain the approvals. Once we get them, we will provide also these regulatory authorizations.

This deliverable has been conceived in the frame of T4.2 “Clinical protocols and requirements”, which is devolted to the organization of the assessment methodology that will be implemented during the development of each use-case at different levels after risk stratification of citizens and clinical scenario. All the designs will be based on the feedback and results after of tasks developed in WP3 and WP5. The following actions will be deployed:

– developing and agreeing on the sampling plan;
– choosing and testing measurement instruments;
– choosing the early diagnosis clinical pathways;
– choosing the diagnosis workflow; and
– planning the data collection and the validation protocols.

After the protocol design (which has already been finalized), all the authorizations required by the regulatory authorities will be obtained.

This deliverable provides the essential regulatory and research documents for the beginning and development of Task 4.3: “General population screening” under which the prospective clinical study will start recruiting participants and gathering data for the LUCIA project.

The content of this deliverable summarizes the clinical protocol for the cohort study in the general population screening and the regulatory authorizations that must be obtained before the enrollment of the first participant in the study.

This deliverable includes the following information:

– Final version of the study protocols of each clinical site as sent to each one of their respective ethics committees.
– Regulatory authorizations required for the enrolment of the first study participant.

The consortium partners have finalized and agreed on the common prospective clinical protocol, which ensures we reach the highest standards of quality and clinical and scientific relevance. The protocols have already been submitted to each one of the Ethics Committees for its approval request in December 2023.

We foresee to obtain the approval of the Ethics Committees in the coming months and start the recruitment of the volunteers that will participate in the prospective clinical study as soon as we get those approvals.

Since the approval has not been obtained yet, we provide in this document the documents of Request for Evaluation of research projects by the Ethics Committees of each clinical site until we obtain the approvals. Once we get them, we will provide also these regulatory authorizations.

ELMUMY represents one of five projects funded by the European Commission through the Horizon Europe program, dedicated to advancing the primary goal of the Cancer Mission program. This initiative strives to enhance comprehension regarding cancer risk elements and the health factors contributing to cancer progression. Joining ELMUMY are four other projects within this domain. GENIAL seeks to delve into gene-environment interactions linked to alcohol-related hepatocellular carcinoma. LUCIA aims to explore risk factors associated with lung cancer. DISCERN aims to unravel the underlying causes of three less understood cancers in Europe-renal, pancreatic, and colorectal. Lastly, MELCAYA focuses on pioneering healthcare strategies for melanoma in younger demographics-children, adolescents and young adults.

These projects have already forged connections and collaborative efforts among their partners, fostering synergies both in scientific exploration and communication. Notably, ELMUMY, with its partner EXEL, has taken the lead in creating in-house a shared a shared video and brochure that encapsulate the essence of all five projects within the cluster.