Periodic Reporting for period 2 - LEGACy (CeLac and European consortium for a personalized medicine approach to Gastric Cancer)
Reporting period: 2020-07-01 to 2021-12-31
Globally, gastric cancer (GC) is the third leading cause of cancer death in both sexes worldwide (723,000 deaths, 8.8 % of the total). Despite multiple attempts to improve GC treatment in recent decades, no strategies have improved prognosis in locally advanced stages (III and IV). Urgent intervention is therefore needed. Our project approach to GC disease, considering the specific characteristics of the identified CELAC and European cohorts, aims to promote the implementation of strategies for the primary and secondary levels of prevention and the advanced stage of the disease.
The LEGACy strategy is based on the work of an international team of experts who are committed to the objectives of this proposal. Its primary aim is to improve GC outcomes by applying personalised medicine at the three levels of prevention in the EU and CELAC populations participating in this Project, all based on an “omics integrative epidemiology” conceptual model as a strategy to be extended worldwide.
The secondary aims of this project are:
1. To implement a personalised medicine strategy at the first level of prevention: The establishment of collaborative work targeted at the general public based on two pillars: a) improving the educational material for the lay population on the risk factors of GC, and b) creating a hospital-based registry for H. pylori treated patients, including a report on therapeutic resistance, in order to assist the update of current protocols with effective eradication therapies.
2. To improve early GC detection through a personalised medicine strategy at the second level of prevention: The education of the lay population on the signs and symptoms of GC and to facilitate their access to endoscopy, both by the implementation of specific measures adapted to each centre characteristics and needs. Furthermore, implementing a prospective hospital‐based GC registry would facilitate data collection and analysis, usually causing GC diagnosis delays and thus, aid in the planification of health strategies at the second level of intervention.
3. To improve the GC treatment approach through the stratification of patients for personalised medicine therapies. A therapeutic approach to GC based on current histological and image criteria (TNM- stage) is insufficient. Molecular landscape, complex patient history, histopathological features of the tumours, environmental factors, together with the personal microbiome and immune landscape must contribute to the development of new therapies and ultimately, to patient treatments and care. LEGACy aims to improve the current knowledge on each of these aspects of the disease and their treatment and thus, deliver high‐risk group identification through the design of a cost-effective algorithm.
4. To analyse regional variations relative to GC among the EU‐CELAC populations. The identification of regional differences based on behavioural, socioeconomic, educational and belief structures, as well as on the healthcare policy backgrounds and the socio-economic strata of each country.
The project outcomes may have a significant impact on GC patients at advanced disease stages, while the implemented actions in primary prevention will directly impact GC incidence.
1. Ferlay J, et al. GLOBOCAN 2012 v1.0 Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11
The LEGACy strategy is based on the work of an international team of experts who are committed to the objectives of this proposal. Its primary aim is to improve GC outcomes by applying personalised medicine at the three levels of prevention in the EU and CELAC populations participating in this Project, all based on an “omics integrative epidemiology” conceptual model as a strategy to be extended worldwide.
The secondary aims of this project are:
1. To implement a personalised medicine strategy at the first level of prevention: The establishment of collaborative work targeted at the general public based on two pillars: a) improving the educational material for the lay population on the risk factors of GC, and b) creating a hospital-based registry for H. pylori treated patients, including a report on therapeutic resistance, in order to assist the update of current protocols with effective eradication therapies.
2. To improve early GC detection through a personalised medicine strategy at the second level of prevention: The education of the lay population on the signs and symptoms of GC and to facilitate their access to endoscopy, both by the implementation of specific measures adapted to each centre characteristics and needs. Furthermore, implementing a prospective hospital‐based GC registry would facilitate data collection and analysis, usually causing GC diagnosis delays and thus, aid in the planification of health strategies at the second level of intervention.
3. To improve the GC treatment approach through the stratification of patients for personalised medicine therapies. A therapeutic approach to GC based on current histological and image criteria (TNM- stage) is insufficient. Molecular landscape, complex patient history, histopathological features of the tumours, environmental factors, together with the personal microbiome and immune landscape must contribute to the development of new therapies and ultimately, to patient treatments and care. LEGACy aims to improve the current knowledge on each of these aspects of the disease and their treatment and thus, deliver high‐risk group identification through the design of a cost-effective algorithm.
4. To analyse regional variations relative to GC among the EU‐CELAC populations. The identification of regional differences based on behavioural, socioeconomic, educational and belief structures, as well as on the healthcare policy backgrounds and the socio-economic strata of each country.
The project outcomes may have a significant impact on GC patients at advanced disease stages, while the implemented actions in primary prevention will directly impact GC incidence.
1. Ferlay J, et al. GLOBOCAN 2012 v1.0 Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11
Our approaches to achieve the aims of the project during this reporting period are presented in Figure 1.
During this period:
- The transcriptomic, genomic, and microbiome protocols were tuned and the characterisations were initiated.
- The e-CRF is currently active for data inclusion. This data is anonymised and appropriately stored by the entire research team.
- The epidemiological questionnaires from clinical studies 1 and 2 were developed and tested by all the researchers. A contingency plan, based on a remote approach, was developed in order to keep moving with the interviews and the questionnaire collection while the COVID-19 restrictions occurred
- The performance of surveys to the civic population on GC knowledge (CS3) strategy was meant to occur face to face. However, due to the COVID-19 pandemic, a contingency plan was developed and applied, performing this study online and through the Legacy website.
- The reliminary results presented at the GAM 2021 are shown in figure 2.
- The educational program, including the training and knowledge exchange of the protocols that will be applied for each GC sample, occurred as ten online educational sessions (until December 2021) on relevant GC topics, and two face-to-face teaching sessions (until December 2021) with international experts.
- The dissemination activities have been carried out in accordance with the project communication plan. The main objective was to raise awareness of the project and prepare for the future dissemination and exploitation of the results.
During this period:
- The transcriptomic, genomic, and microbiome protocols were tuned and the characterisations were initiated.
- The e-CRF is currently active for data inclusion. This data is anonymised and appropriately stored by the entire research team.
- The epidemiological questionnaires from clinical studies 1 and 2 were developed and tested by all the researchers. A contingency plan, based on a remote approach, was developed in order to keep moving with the interviews and the questionnaire collection while the COVID-19 restrictions occurred
- The performance of surveys to the civic population on GC knowledge (CS3) strategy was meant to occur face to face. However, due to the COVID-19 pandemic, a contingency plan was developed and applied, performing this study online and through the Legacy website.
- The reliminary results presented at the GAM 2021 are shown in figure 2.
- The educational program, including the training and knowledge exchange of the protocols that will be applied for each GC sample, occurred as ten online educational sessions (until December 2021) on relevant GC topics, and two face-to-face teaching sessions (until December 2021) with international experts.
- The dissemination activities have been carried out in accordance with the project communication plan. The main objective was to raise awareness of the project and prepare for the future dissemination and exploitation of the results.
The LEGACy consortium consolidated during these three years. The multidisciplinary teamwork pushed the project to move forward with the different tasks and it has been actively working on the recruitment of the three CS, as well as on the HP and GC register implementation. The consortium also prepared a detailed contingency plan to mitigate the adverse effects of the COVID-19 restrictions.
Beyond the expected impact, our project identified three main areas to proceed, were we are currently working on:
• The Educational program: as mentioned before.
• Network biobanks in EU and CELAC countries had been already established. Samples stored at these biobanks will be available for the researchers of this consortium for further analysis during this project, or beyond the project, or will be destroyed, depending on the patient’s wishes.
• Data management beyond the project: Before the end of the project, the data generated from each sample determination will be deposited in EU and CELAC genomic data repositories that will be available to the entire scientific community.
Both tasks, the ones associated with the clinical studies, and the ones linked to the educational program, showed a positive impact. The promoted dissemination and educational activities delivered the message directly to the general population as well as to the scientific community, via web and social networks.
During the third reporting period, after the completion of the sample characterisation, we will be able to integrate the data and develop the diagnosis algorithm. Then, we will be able to assess the potential benefits of the implemented prevention strategies in the selected populations.
Finally, economic-wise, it is too soon to perform an overall assessment or attire conclusions.
Beyond the expected impact, our project identified three main areas to proceed, were we are currently working on:
• The Educational program: as mentioned before.
• Network biobanks in EU and CELAC countries had been already established. Samples stored at these biobanks will be available for the researchers of this consortium for further analysis during this project, or beyond the project, or will be destroyed, depending on the patient’s wishes.
• Data management beyond the project: Before the end of the project, the data generated from each sample determination will be deposited in EU and CELAC genomic data repositories that will be available to the entire scientific community.
Both tasks, the ones associated with the clinical studies, and the ones linked to the educational program, showed a positive impact. The promoted dissemination and educational activities delivered the message directly to the general population as well as to the scientific community, via web and social networks.
During the third reporting period, after the completion of the sample characterisation, we will be able to integrate the data and develop the diagnosis algorithm. Then, we will be able to assess the potential benefits of the implemented prevention strategies in the selected populations.
Finally, economic-wise, it is too soon to perform an overall assessment or attire conclusions.