Servizio Comunitario di Informazione in materia di Ricerca e Sviluppo - CORDIS

FP6

GENEPI-ENTB 2 Sintesi della relazione

Project ID: 36437
Finanziato nell'ambito di: FP6-EURATOM-RADPROT
Paese: Belgium

Final Report Summary - GENEPI-ENTB 2 (GENEtic pathways for the Prediction of the effect of Irradiation-European normal an tumour tissue bank and data base)

Huge advances in the fields of genomics, proteomics and bio-informatics have thus far not lead to equally spectacular breakthroughs at the translational level. One of the major impediments for progress in science is the fragmentation of research efforts, resulting in valuable data being locked up in distributed, incompatible databases and precious bio-repositories collecting dust in the attics and basements of isolated research labs.

At some point, at a research meeting focusing on radiobiology, it started dawning on the RT community that further progress in the prediction of treatment outcome would be illusory unless RT got its act together and started pooling knowledge and resources to move also radiation sciences forward into the age of genomics.

Putting this insight into practice, they decided to create a European tissue bank and database, dedicated to research in the response to radiation. Their idea found a resonance and funding in the EURATOM Fifth Framework Programme (FP5) priorities in the field of radiation protection.

In the medical world, collaboration and the exchange of expertise is common currency but pooling and sharing tangible proprietary assets such as tissues was yet uncharted territory. It was soon realised that a central tissue bank was not a realistic proposal. Not only ownership issues but also hurdles as mundane as the maintenance of freezers with a steady supply of liquid nitrogen over a long period of time cropped up, discounting even the danger of the destruction of all the samples in the event of a central power failure.

The concept of a 'virtual distributed European tissue bank' linked to a central database with the possibility of web-based de-central data input and data-mining started to take shape. The next question was: what to collect? A consensus grew that prospective tissue and data collection with standardised procedures for tissue sampling and for the documentation of patient-, treatment- and follow-up data should be the first priority. Thus, while creating a database available for future clinical trials and for the partners' own clinical studies, an infrastructure would be built up for future research. The great advantage would be homogeneous datasets with common criteria for outcome assessment. The disadvantage: it would take many years before a sufficient quantity of data and tissues would be available with follow up periods sufficiently long for the envisaged research. The solution for filling this time and quantity gap was to include also material from past high quality trials in which treatment and follow up data had been meticulously recorded, irrespective of the problems arising from the great heterogeneity of the data-bases, as long as the minimum criteria set out by the consortium, expressed in a minimum data set and the availability of lymphocytes for research could be guaranteed.

It was decided to focus on the main tumour sites: breast, head and neck, lung, prostate and rectum and to collect a wide range of samples: plasma, buffy coat, peripheral blood lymphocytes, DNA, snap frozen and gradually frozen blood, skin fibroblasts, mucosa, whole blood, tumour tissues and living cells.

Needless to say that a lot of energy was invested in defining the kind of patient, disease and therapy related data that would be necessary to maximise the potential for future research and to store them in an ethically vetted, secure, user-friendly and easily searchable database.

By the end of GENEPI- ENTB 1, a complete set of common guidelines and procedures had been developed and data had been collected on 5844 radiotherapy patients and 960 healthy controls from whom 12120 tissues had been obtained and documented.

GENEPI II successfully reached and exceeded its objective for the quantitative development of the database and created in addition a dedicated database for over-reactors.

Procedures for the different levels of quality checks were laid down in a comprehensive set of standard operating procedures. The most important of these checks, the dosimetric audit of all the departments contributing more than 150 tissues, was completed. And so has the Quality assurance (QA) check of treatment plans for the patients entered in the over-reactor data base.

Informazioni correlate

Reported by

EUROPEAN SOCIETY FOR THERAPEUTIC RADIOLOGY AND ONCOLOGY
BRUXELLES
Belgium