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FORECEE Report Summary

Project ID: 634570
Funded under: H2020-EU.3.1.2.

Periodic Reporting for period 1 - FORECEE (Female cancer prediction using cervical omics to individualise screening and prevention)

Reporting period: 2015-09-01 to 2017-02-28

Summary of the context and overall objectives of the project

The FORECEE project is focused on the shared ambition of a group of leading European clinicians and researchers to promote women’s health and prevent female cancers. The radical progression the consortium wish to see is the implementation of omics based methods into wide scale clinical practice for the stratification and risk prediction of cancers that are hormone-associated and specific to women (breast, ovarian, endometrial and cervical cancers). These represent more than 47% of all cancers in women and amongst them are cancers with a 5-year survival rate of less than 40%.
The FORECEE programmes is aligned with the novel concept of “P4 Medicine” (predictive, preventive, personalized and participatory) seeking to develop a multi-omics enabled risk prediction tool and to translate the tool’s output into recommendations for new clinical pathways for individualised screening and prevention of all female cancers that can be implemented on a national/international scale (Figure 1).
The FORECEE consortium will develop these tests by examining cervical cells, looking at:
• Epigenetic factors (i.e. the cell’s ‘software’) which captures environmental and lifestyle risk factors
• Genetic factors (i.e. the cell’s ‘hardware’)
• Microbial factors (the viruses and bacteria present in the vagina) that contribute to the development of female genital tract cancers.
FORECEE will establish these tests by analysing women with and without a cancer and will then validate these tests using an existing population-based set of cervical epithelial cells s to validate whether the tests accurately predict cancer risk in women who went on to develop female cancers years after they donated the samples. FORECEE will also assess whether implementing these tests at a population level is cost effective and whether it offers a positive balance between long-term benefits and the risk of harm to women. In addition, the project will explore women’s attitudes to individualised predictive risk modelling. It also includes an ethical, legal, regulatory and social impact assessment.
In analogy to the smear test which uses cervical cytology (morphology) to predict the cervical cancer risk, we aim to develop Women’s cancer risk IDentification tests (WID tests) based on multi-omics data. The tests will take into account the different needs of women depending on their age:
For pre-menopausal women the tests are aimed to (i) identify women with BRCA1/2 mutations or Lynch syndrome (indicating a higher risk of developing breast, ovarian or endometrial cancer at young age) and (ii) improve on the specificity of existing tests for HPV (human papilloma virus) and indicate which women are at high risk of developing cervical cancer within the next 3 years.
For postmenopausal women we will predict the risk for (irrespective of their inherited predisposition) to develop breast, ovarian, cervical and endometrial cancers within the next 5-10 years.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

So far the consortium has recruited 2,993 volunteers (each participant provided 3 subsets of samples therefore, total number of specimens processed so far are 8979) which represent approximately 60% of the target. In addition we have already identified >1000 cervical smear samples from the archived set to establish the test which aims to improve specificity of HPV testing. DNA methylation of 1000 samples has already been analysed and analyses of the cervical smear microbiome is underway.
We have analysed DNA methylation in several subsets of samples and have developed algorithms that allow us to adjust for the different cell-type composition of the cervical smear samples (i.e. proportion of epithelial cells, granulocytes, lymphocytes and monocytes).
A FORECEE information leaflet was produced taking into consideration women’s informational needs as revealed by focus groups, international patient information examples and good practice health guidelines available from the EU. Based on this leaflet, an extensive survey was undertaken in 1675 women in the Czech Republic, Germany, Italy, Sweden and the UK. The preliminary results have indicated that there was a positive attitude from survey respondents across the EU member states (Germany, Italy, Sweden, and the UK).
A detailed literature survey has been conducted on the cost effectiveness of existing early detection and prevention strategies for women’s cancers (ovarian, endometrial, breast and cervical cancer).
One of the first main stakeholder events to take place was the FORECEE workshop in Berlin, held in February 2017. More than 60 people attended this two-day workshop including representatives from healthcare stakeholder organisations from a number of European countries. The first day considered the different aspects of women’s cancer screening provision and funding within the EU, and included an active brainstorming and breakout session where delegates considered the main issues, barriers and potential solutions to the introduction of a new screening test into national screening programmes. On day two of the workshop, consideration was given to the ethical issues associated with the introduction of a new cancer screening test.
We have developed a webpage ( and a range of communication templates have been produced and numerous dissemination activities were already captured and reported to the EC for this project.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Female cancers place a high burden on society and healthcare systems. More than 516,000 new cases of breast, ovarian, endometrial and cervical cancer are diagnosed in EU-27 countries each year. An additional 400,000 women receive treatment for cervical cancer precursors identified following cervical screening. Almost half of all cancers in women are female specific hormone-related cancers. In addition to the personal suffering caused, these cancers represent a significant economic burden. The clinical situation for each of the cancers is different, but in all cases redefining the clinical pathway through tailored screening and prevention programmes will offer significant advantages to female health promotion. FORECEE will enable the introduction of risk-based screening strategies that are better than those proposed on the basis of current evidence.

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