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  • Periodic Report Summary 4 - FRAILOMIC (Utility of omic-based biomarkers in characterizing older individuals at risk for frailty, its progression to disability and general consequences to health and well-being - The FRAILOMIC Initiative)

FRAILOMIC Report Summary

Project ID: 305483
Funded under: FP7-HEALTH
Country: Spain

Periodic Report Summary 4 - FRAILOMIC (Utility of omic-based biomarkers in characterizing older individuals at risk for frailty, its progression to disability and general consequences to health and well-being - The FRAILOMIC Initiative)

Project Context and Objectives:
The main objective of FRAILOMIC is to develop clinical instruments (composed by clinical BM, omics based laboratory BM and classical laboratory BM):
1) To predict the risk of frailty.

2) To improve the diagnostic accuracy of frailty in day to day practice.

3) To assess the prognosis of frailty in terms of disability and other adverse outcomes.
In addition, the project has also three secondary objectives:
1) To assess the interactions between –omic based BM and nutrition and physical exercise (useful to know the potential response to treatments) on the natural history of frailty.
2) To test whether the above stated instruments are also useful for special populations: people with diabetes, obesity and people with cardiovascular disease.
3) To test the differential validity of Fried´s criteria as compared with those described in the Toledo Study of Healthy Aging (TSHA) and Three-City-Bordeaux studies.

Project Results:
During these first three years of the project, the Frailomic partners have undergone some significant challenges. The Frailomic study is progressing at a satisfactory pace, and significant achievements have been made during this period:
The main work in this period has been focused on these tasks:
- Concluded the harmonization plan with the intervention of all partners.
- Selected the biomarkers (clinical and biological markers) of the validation phase thorough of well-planed analysis
- Selection of eligible patients from cohorts participating in validation phase according to specific inclusion and exclusion criteria.
- Establish technical platform and assay development for the data of exploratory phase.
- The set up of the validation phase has been established: cohorts participating in validation phase have confirmed the availability of samples that could be shared for our project. The compilation of clinical markers already done in cohorts has also started, to perform the same harmonization process that has been done for exploratory phase.
- Development of the Dissemination and Exploitation Plan. Some publications have already been proposed to a better diffusion of the project in the international scientific community. On the other hand was development the flowchart to publication process.
- Development of TIME methodology for Reducing uncertainty in the selection process of innovative technologies in the early stages of development.
Regarding the setting up of the basis for the development of the project the coordinator team has developed all the steps to ensure an appropriate course of the project since its start. All deliverables expected during this period have been sent to European commission, complying with the norms of correct functioning and management of the project.
Without no doubt the most important tasks performed during these 36 months have been all the steps related to achivievement the biomarkers to probe in the validation phase. During these 3 years we have selected the patients to be included in the validation phase, coordinated the distribution of available samples between participating laboratories according to their specific requirements for analysis, created an unified system of codification of samples and provide adequate labelling for identification of samples, organized all the issues for the correct shipment of samples (coordinated both with bio banks, responsible of the cohorts, and persons in charge of reception in laboratory of destination).
Another key task that has been achieved during this third year of the project has been the harmonization process for the data already available and provided by cohorts. This harmonization process it is very important not only to summarize the information from cohorts, but also to allow a better analysis of the data in order to extract information related to our objectives.
About the selection of the patients for validation phase and the identification of potential biomarkers of risk, diagnosis and prognosis of frailty in old people, we have ensured that all the procedure to reach this task are well established, and ready to be done on time. We contacted each main researcher to coordinate the process in this phase.
Regarding exploitation and dissemination plan, a web site has been updated and we set up the flow chart to the process publication. It was launched in the Mallorca Meeting. On the other hand, some publications was launched.
Regarding the Exploitation plan, we made the TIME methodology.with the objective to reduce the uncertainty of innovative technologies.

Potential Impact:
FRAILOMIC tries to refine, using –omics, the epidemiological-based concept of frailty to make it useful in other (clinical and non-clinical) settings, providing tool-kits to the health workers that allow them to assess the risk of developing frailty (risk BM), to detect frailty (diagnostic BM), and to assess the evolution of frailty (prognostic BM) and its likely response to treatment (predictive BM), thus bridging the gap between epidemiology and care practice.
Although some of the biomarkers that will be tested are not absolutely new (they have shown some kind of association with frailty in human beings or with longevity in animal models of aging or related diseases), an additional novelty of the project stems from its capacity to find out its applicability to care practice and in combination.
Many of the techniques to be used are really innovative. The groups participating in the consortium have developed their own technology to measure many of the biomarkers that will be assessed, have developed innovative and clinically sound mathematical and statistical methods of analysis of biomarkers, and the cohorts participating in the project are really representative of the older populations in Europe and other parts of the world (America, Asia and Africa), raising the potential to find biomarkers with clinical utility world-wide.
The project is conceived from the view of the complementariness in two different ways. Our approach will embrace different –omics in the same individuals (genomics, proteomics and metabolomics), allowing the building of complementary data to be incorporated in a same diagnostic tool. In addition and perhaps more relevant, is the complementariness of the expertise of the different groups involved in the proposal: basic scientists, epidemiologists, clinicians and bioinformatics.

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