Publications

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.

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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.

This report summarises the conclusions of the common first year annual meeting of the “Understanding (risk factors & determinants)” and “Prevention & Early detection (Screening)” clusters within the EU Cancer Mission. 13 projects took part, showcasing the advances achieved within each project during the first year. Alongside project updates, various topics were discussed as requested by the European Commission (EC, encompassing): research and innovation, citizen engagement, addressing inequalities, data management plan (DMP), dissemination and communication, and collaborative work among the cluster projects were presented, and common aims were identified. A fruitful discussion with the HaDEA representative was conducted and outlines for future work of the clusters was described mainly towards establishing synergies and “best practices” across the projects to pave the way for future collaboration.

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This report introduces the guidelines for the monitoring, control, and execution of the different administrative and financial aspects of the project to ensure that the action described in the Grant Agreement is properly implemented, following the rules and procedures of the European Commission. The first part details the management structure of the project, including the different governing structures (such as the General Assembly or the Project Board) and the roles and responsibilities of the partner institutions involved in them. The work plan for the project is also detailed, including a list of work packages broken down by their respective tasks, the effort in person month, the assigned responsible institution and the delivery due date. Gantt and PERT charts are also included to make it easier to understand the distribution and relationships between the different tasks to be performed. The different project deliverables and milestones are listed including the responsible institution, due date and means of verification. Finally, several types of reporting to be performed during the project are presented, both internally and to the European Commission.

This report introduces the concept EU Mission on Cancer and its main objectives, which range from understanding the disease to the development of new strategies for prevention, treatment and improving the quality of life of patients. LUCIA belongs to a cluster of five projects financed by the Horizon Europe programme (HORIZON-MISS-2021-CANCER-02-03) aimed at better understanding the impact of risk factors and health determinants on the development and progression of cancer. In this report, the areas for scientific collaboration between the projects belonging to this cluster are presented, which include the following aspects:

• Sharing and agreeing on common practices for data/material management.
• Sharing and cross-comparison of risk factors and molecular features.
• Cross-comparison and integration of risk stratification/early diagnosis tools.
• Sharing of best practices on implementation of healthcare policies.

Finally, the particular actions for the practical implementation of collaborations between the projects in the cluster are presented, which include the organization of Understanding cancer cluster meetings and the creation of a data management board.

Lung cancer is the biggest cancer killer worldwide, and although tobacco smoking has long been recognised as the major risk factor, this reason fails to clarify many cases. Hence, LUCIA aims to establish a novel toolbox for discovering and understanding new risk factors contributing to lung cancer development. Key components of the toolbox for analysing personal and external risk factors include retrospective and prospective cohort databases, Artificial Intelligence models, novel non-invasive sensors and multi-omics.
The resulting evidence within LUCIA will be translated into policymaking recommendations for implementation in screening programs.

To accomplish the objectives of the LUCIA project, partners in LUCIA will both re-use data from various existing data sources (such as data provided by the clinical partners, public data sources for environmental and sociodemographic factors, the Esther cohort study…) and generate new data during the observational cohort study (including electronic health records, sensor information, CT scan images, polygenetic scoring…).

The partners involved in LUCIA are committed to adhering to the FAIR principles of data management throughout their project. We are striving to implement several measures to ensure that data generated and re-used within LUCIA is findable, accessible, interoperable, and reusable.

Findability will be ensured by assigning unique and persistent identifiers to datasets, providing rich metadata using controlled vocabularies, adopting open data formats and preparing datasets for harvesting. LUCIA partners also aim to align with the European Health Data Space, which will impact the chosen standards, vocabularies, etc. Accessibility will be ensured by depositing the data after the project ends into a trusted and accessible repository, which is intended to serve as a research platform that supports the UNCAN.eu initiative. Interoperability will be ensured by adopting industry-standard frameworks, such as the OMOP data model, HL7, IHE ITI and Open mHealth standards, and alignment with relevant initiatives
and projects, such as the OHDSI oncology working group, the EHDEN initiative, etc. Reusability will be ensured by sharing documentation and a processing log for data traceability and by maintaining data quality, integrity and reliability.

The consortium is also taking several measures for data security. During the project lifetime the data in LUCIA will be accessible only by project partners, with the aim of serving the project research purposes, and through secure and controlled channels. Moreover, the partners currently envisage a federated infrastructure for analysis of clinical data and additional security measures will be implemented for prospective data collected during the observational cohort study.

Ethics considerations are also a part of the consortium’s data management. Various ethics issues may arise, for example, in relation to the clinical trials to be conducted or the project’s use of AI. The biggest issue that may impact data sharing in LUCIA is the processing of personal data. Partners will fully comply with the GDPR’s principles, and this may mean that certain data is not collected at all, or only shared in an anonymised form.

Finally, the LUCIA project is part of the Cancer Mission cluster of projects on “Understanding” and “Prevention, including screening”. A common chapter presents the areas for data management cooperation within each of these clusters. Many commonalities in data re-use and generation and in FAIR data management have already been identified and will be explored further in regular meetings of the data management group of each cluster.

This data management plan will be a living document as the LUCIA project progresses. Regular updates will be implemented to incorporate more detailed information and reflect the advancements of this complex project. By adhering to the principles of FAIR data management, prioritising data security, and upholding ethical considerations, the consortium aims to not only maximize the value and reusability of the project’s data but also ensure the responsible and transparent conduct of research.