Proposals under this topic should aim to deliver results that are directed and tailored towards and contribute to all of the following expected outcomes:

• Healthy people and in particular people at risk will benefit from microbiome tests and programmes that can discover and predict their transition to cancer before the onset of disease.
• People will have a better understanding of risks and will be enabled to address risks early by following treatments or adapting their lifestyles, including nutrition and other interventions.
• Physicians will be able to start cancer treatments earlier with a higher success rate.
• Policy makers and authorities will be enabled to develop and implement advanced and strategic programmes addressing cancer prevention.

Scope:

This topic will contribute to the achievement of the EU Cancer Mission’s objective to achieve better cancer prevention and early detection. The focus is on the development of validated microbiome tools, an assessment of predispositions, the comparison with other predictive tools and risk modelling approaches.

Cancer often develops over several years and progresses silently before symptoms appear. Some cancers are diagnosed at a very late stage, when the disease is nearly incurable. Early and sensitive biomarkers are beneficial for preventive strategies and the survival of patients especially when tests are minimally invasive and simple to perform. The human microbiome is correlated with this process of oncogenesis and tumour progression. The deterioration of the human microbiome towards dysbiosis should be monitored and used as an early predictive biomarker. The potential of the microbiome should be exploited to deliver important contributions to cancer prevention and early detection strategies before the onset of disease especially for high-risk patients.

Prevention of cancer through early detection is most efficient in fighting cancer and saving lives. Large microbiome biobanks and registries exist at national and international levels to collect and store microbial samples with the intention to analyse and share microbiome data for research and healthcare. The One Million Microbiomes from Human Project has been launched by several countries to build the largest human microbiome high quality database and to provide advanced life science tools for future healthcare.

The intention is to accelerate the translation of microbiome knowledge to predict and prevent cancer earlier, before the onset of disease, through the development of personalised approaches and tools. The promise of these tools is evident because people could anticipate cancer while they would still have time to act before the onset of the disease. In case of certain types of cancer, earlier treatment could improve lives or even cure patients in line with the goal of the EU Cancer Mission.

The tools should be based on the collection of a high number of longitudinal samples over several years, they should be validated and their prediction power compared with other minimally invasive (liquid biopsy) tests. To use the resources most efficiently, the tools should be supported by risk modelling approaches and AI technologies.

Proposals should address all of the following:

• Development of microbiome tools for earlier, better and personalised prediction and prevention of cancer before the onset of the disease; if possible 2 years before the onset of the disease. Proposals should deal with several types of cancer if possible.
• Assessments of predispositions, AI risk modelling approaches and organ/body simulations.
• Collaboration with large cohorts/registries from different communities, usage of existing microbiome and clinical data in combination with and generation of new data. These data could include other predictive signs such as sensations of fatigue, unusual pain, weight loss or other body changes.
• Citizen engagement could be included with data and sample collections as well as educational programmes.
• Comparison with other minimally invasive liquid biopsy and other tests concerning their predictive power, simplicity, cost-benefits and potential for commercialisation.
• Validation of the tests in an independent cohort. Development of guidelines that help to manage risk factors such as lifestyle or diet. The outcome and expertise of ongoing EU and International initatives and the International Cancer Microbiome Consortium could be considered for the reliability of the tests and guidelines to be developed. Age, sex and gender differences should be duly considered.

The successful proposal is expected to build on resources made available by the Knowledge Centre on Cancer (KCC)^[1] to foster EU alignment and coordination.

The successful proposal will be asked to join the 'Prevention and Early Detection' project cluster of the EU Cancer Mission^[2] and should include a budget for networking, attendance at meetings and joint activities^[3]. The Commission will facilitate coordination of these activities.

[1] Hosted by the European Commission's Joint Research Centre (JRC). Especially through the ’European Guidelines and Quality Assurance Schemes for Breast, Colorectal and Cervical Cancer Screening and Diagnosis‘, and the ’European Cancer Information System (ECIS)’ and the ’European Cancer Inequalities Registry (ECIR), see https://knowledge4policy.ec.europa.eu/cancer_en

[2] In order to address the objectives of the EU Cancer Mission, participants will collaborate in project clusters to leverage EU-funding, increase networking across sectors and disciplines, and establish a portfolio of EU Cancer Mission R&I and policy actions.

[3] examples of these activities are research or research capacity, organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Proposals are not required to include details of these activities, as they will be defined during the grant agreement preparation and during the life of the project.