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Archive's tissues: improving molecular medicine research and clinical practice

Final Report Summary - IMPACTS (Archive's tissues: improving molecular medicine research and clinical practice')

All the tissues taken from patients for diagnostic or therapy reasons are routinely fixed and paraffin-embedded and, after few sections are cut for histopathological diagnosis, those tissues are stored in archives often for decades. For this reason they are called 'archive tissues'. Such tissues can be a very important resource for molecular analysis in the research and clinical practice. The reason for this is that in many cases the only tissue available for molecular clinical analysis in a patient is a small fixed and paraffin-embedded biopsy tissue. Medicine has been improving the possibility to personalise diagnosis and treatment through the research and application of molecular biomarkers. The use of archive tissues will enhance the amenability of tissues for research and clinical practice because of their availability in any hospital.

The coordination action IMPACTS involved 20 participants in 11 countries. Among them were major experts in molecular analysis in archive tissues and those that first developed these methods.

The group has validated and standardised these molecular methods, in DNA and RNA analysis, and specific guidelines have been prepared and discussed for clinical application. This step is extremely important to be able to diffuse the methods at the European level for a clinical application. The group has also studied innovative techniques such as new fixatives that are preserving macromolecules, e.g. proteins, in the same way as in fresh frozen tissues.

The introduction of proteomics research and clinical application is also one of the priorities, with the development of two strategies. The first one is a new method that allows protein analysis in formalin-fixed tissues (most of the tissues today are formalin-fixed). The second one is the use the new fixatives in order to obtain a perfect preservation of proteins. These developments will make it possible to perform molecular analysis at the DNA, RNA and protein level, directly in those tissues in which the clinical diagnosis was defined, even in a tiny biopsy, with a careful selection of the cells of interest. The group has also prepared multicentric studies in human archive tissues, especially for the validation and standardisation of molecular analysis and to develop methods for the guidelines.

The activity was also related to the preparation of tissue bio-banking rules specific for archive tissues, for which specific guidelines are necessary also in archive tissues. A new project to define a network of archive tissue virtual banking among the participants in the project was developed. This network was included in the European Biobanking Infrastructure (BBMRI).

At the end of the project, in order to continue the activity of Impacts, a pan-European archive tissue biobanking network was begun, starting from the already existing Impacts network. This network is being developed in collaboration with the European Society of Pathology (ESP) and BBMRI.

From the second year onwards - bioethics issues were discussed to prepare specific approaches in the use of archive human tissues for clinical research. An international meeting on bioethics in the translational research use of archive tissues was organised with the participation of the Impacts groups and the experts of BBMRI. This has given the basis for the specific management of the archive tissue biobanks in Europe.

The project was supposed to last two years, but a 12-month extension was granted, until February 2010, to allow the participants to better fulfil their final goals, to improve and accelerate molecular medicine research and clinical practice using archive tissues.