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Hematological Oncology Hematol Oncol 2005; 23: 54–56 Published online 10 October 2005 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/hon.749 Review Article Current challenges of human tumour banking Manuel M Morente* and Soledad Alonso Spanish Tumour Bank Network, Molecular Pathology Programme, Centro Nacional de Investigaciones Oncolo´gicas (CNIO), Madrid, Spain Abstract Tumour Banks (TB) are called upon to play a central role in Oncological translational research. TB have been existing since Pathology Departments started storing blocks of tissue samples, but in keeping this role they must face some urgent challenges including: an updated definition of hospital TB, integration into clinical trials and projects of excellence, networking and a new framework for ethics and laws. Current TB definition includes not only tissue storage, but also a series of hospital proto- cols that allow molecular studies of tumour and normal samples. The real value of these pro- tocols and samples appears with scientific projects of excellence and integrated in clinical trials. Most of these trials need for a large number of cases with homogeneously treated tis- sue samples in the context of multicentre and multinational projects. Thereby, networking appears the best solution for TB to expand. Networking implies standardised technical pro- cedures, a strict quality control programme, homogeneous ethic requirements and an open mentality for sharing. In the international setting the major challenge for networking is the various laws and customs in the different countries. To bring these diverse legislations together is, perhaps, the most important challenge for TB Networking in the very close future. Copyright # 2005 John Wiley & Sons, Ltd. Keywords: tumour bank; translational research; cancer Introduction Current oncological research has three main characteris- tics: The capacity for large-scale studies in genomics and proteomics, the high sensitivity of the current techno- logical tools and the transfer from basic to clinical research, the so-called translational research. These three characteristics depend on specially procured tissues: large-scale molecular studies need large numbers of cases to identify new parameters of clinical value, highly sensitive techniques require appropriately handled sam- ples and translational research needs homogeneous tis- sue-sampling protocols to avoid the bias of multicentre studies. In keeping with these characteristics, tumour banks are called upon to play a central role. 1–3 Some of the more urgent challenges in Tumour Banking include: an updated definition of hospital tumour banks, integration into clinical trials and projects of excellence, networking and a new framework for ethics and laws. 4 An updated definition of hospital tumour banks Tumour Banking requires the collection, freezing and storage of neoplastic and normal tissues, and these activ- ities must be considered routine in the Departments of Pathology. 2,5 However, this must be seen from the hospi- tal point of view, and Tumour Banks should include not only solid neoplasms, but also haematological malignan- cies, serum banks, normal tissue from the same organ and/or blood, minimally passaged tumour cell lines for drug checking and, most importantly, protocolised clinical data. From a historical point of view Tumour Banks have been existing since Pathology Departments started storing blocks of tissue samples, but the current Tumour Bank definition includes not only tissue storage, but also a series of hospital protocols that allow molecular studies of tumour samples. A Tumour Bank is not only a pathologist’s activity, but also a global facility for hospital staff including surgeons, clini- cians, hospital managers and, obviously, pathologists. The basic aspects of tumour banking include homoge- neous and suitable protocols for the collection, handling, storage and use of frozen samples for research, teaching, and cancer patient care and a suitable quality assurance pol- icy and controls. To allow these activities to be carried out properly, a professional management is required following the ‘honest broker’ design. It is of the greatest importance to stress that Tumour Banks are by themselves of little value: they are not a goal but only tools, and like any tool their usefulness depends upon the intended goal. The real value of Tumour Banks appears with scientific projects of excellence and integrated in clinical trials. Copyright ß 2005 John Wiley & Sons, Ltd. *Correspondence to: Manuel M. Morente MD, PhD, Spanish Tumour Bank Network, Molecular Pathology Programme, Centro Nacional de Investigacio- nes Oncolo´gicas (CNIO), Melchor, Fernandez Almagro, 3 28029-Madrid, Spain. E-mail: mmorente@cnio.es Received 24 August 2005 Accepted 24 August 2005

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Hematological OncologyHematol Oncol 2005; 23: 54–56Published online 10 October 2005 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/hon.749

Review Article

Current challenges of human tumour banking

Manuel M Morente* and Soledad Alonso

Spanish Tumour Bank Network, Molecular Pathology Programme, Centro Nacional de Investigaciones Oncologicas (CNIO), Madrid, Spain

Abstract

Tumour Banks (TB) are called upon to play a central role in Oncological translationalresearch.TBhave been existing sincePathologyDepartments started storing blocks of tissuesamples, but in keeping this role they must face some urgent challenges including: anupdated definition of hospital TB, integration into clinical trials and projects of excellence,networking and a new framework for ethics and laws.

Current TB definition includes not only tissue storage, but also a series of hospital proto-cols that allowmolecular studies of tumour and normal samples. The real value of these pro-tocols and samples appears with scientific projects of excellence and integrated in clinicaltrials. Most of these trials need for a large number of cases with homogeneously treated tis-sue samples in the context of multicentre and multinational projects. Thereby, networkingappears the best solution for TB to expand. Networking implies standardised technical pro-cedures, a strict quality control programme, homogeneous ethic requirements and an openmentality for sharing.

In the international setting the major challenge for networking is the various laws andcustoms in the different countries. To bring these diverse legislations together is, perhaps,the most important challenge for TB Networking in the very close future.Copyright# 2005 John Wiley & Sons, Ltd.

Keywords: tumour bank; translational research; cancer

Introduction

Current oncological research has three main characteris-tics: The capacity for large-scale studies in genomics andproteomics, the high sensitivity of the current techno-logical tools and the transfer from basic to clinicalresearch, the so-called translational research. These threecharacteristics depend on specially procured tissues:large-scale molecular studies need large numbers ofcases to identify new parameters of clinical value, highlysensitive techniques require appropriately handled sam-ples and translational research needs homogeneous tis-sue-sampling protocols to avoid the bias of multicentrestudies.

In keeping with these characteristics, tumour banks are

called upon to play a central role.1–3 Some of the more

urgent challenges in Tumour Banking include: an updated

definition of hospital tumour banks, integration into clinical

trials and projects of excellence, networking and a new

framework for ethics and laws.4

An updated definition of hospital tumour banks

Tumour Banking requires the collection, freezing andstorage of neoplastic and normal tissues, and these activ-ities must be considered routine in the Departments ofPathology.2,5 However, this must be seen from the hospi-

tal point of view, and Tumour Banks should include notonly solid neoplasms, but also haematological malignan-cies, serum banks, normal tissue from the same organand/or blood, minimally passaged tumour cell linesfor drug checking and, most importantly, protocolisedclinical data.

From a historical point of view Tumour Banks have been

existing since Pathology Departments started storing blocks

of tissue samples, but the current Tumour Bank definition

includes not only tissue storage, but also a series of hospital

protocols that allow molecular studies of tumour samples. A

Tumour Bank is not only a pathologist’s activity, but also a

global facility for hospital staff including surgeons, clini-

cians, hospital managers and, obviously, pathologists.

The basic aspects of tumour banking include homoge-

neous and suitable protocols for the collection, handling,

storage and use of frozen samples for research, teaching,

and cancer patient care and a suitable quality assurance pol-

icy and controls. To allow these activities to be carried out

properly, a professional management is required following

the ‘honest broker’ design.

It is of the greatest importance to stress that Tumour

Banks are by themselves of little value: they are not a

goal but only tools, and like any tool their usefulness

depends upon the intended goal. The real value of Tumour

Banks appears with scientific projects of excellence and

integrated in clinical trials.

Copyright � 2005 John Wiley & Sons, Ltd.

*Correspondence to:Manuel M. Morente MD, PhD,Spanish Tumour Bank Network,Molecular Pathology Programme,Centro Nacional de Investigacio-nes Oncologicas (CNIO), Melchor,Fernandez Almagro, 328029-Madrid, Spain.E-mail: [email protected]

Received 24 August 2005

Accepted 24 August 2005

Page 2: Current challenges of human tumour banking

Nevertheless, it is necessary to recognise the high value

of human sample biorepositories not only for translational

and clinical researchers, but also for basic investigators as

well.

Integration into clinical trials and projectsof excellence

The most important function of a Tumour Bank in Trans-lational Research is its close integration in clinical trialsof excellence, including molecular profiling by using fro-zen samples with protocolised clinical information andstrict criteria of anonimisation.6

In fact, the mayor hallmark of the activity of a bioreposi-

tory is not the number of samples it contains, but the impact

factor of the publications with specific reference to the bank

as the tissue source.1

Key clinical issues would be: developing new molecular

prognostic markers, predicting who needs systemic adju-

vant treatment (mainly in lymph node negative patients

with breast carcinoma, colorectal carcinoma and others),

predicting the response to a given treatment and developing

novel therapies.

Integration of Tumour Banks and Clinical Trials is the

most urgent and critical challenge for Translational

Research in Cancer. For this purpose we need networking

and an updated legal scenario.

Networking

Current oncological research and Clinical Medicinemust be based on evidence. The study of a large numberof cases and many assays are required before the clinicalvalue of a new marker or, more strictly, a new drug can beaccepted. This entails the need for a large number of fol-lowed-up cases with homogeneously treated tissue sam-ples in the context of multicentre and multinationalprojects.2

The problem is that there is no institution in the world,

and almost no country on the planet, that is capable of col-

lecting a sufficiently large number of cases for studying. For

this reason, networking appears the best solution for

Tumour Bank to expand. Spanish,7 UK, Irish,8 EORTC,9

or TUBAFROST10 networks, amongst others, can be taken

as models in this issue in Europe.

Tumour Bank Networking has many advantages: access

to a larger homogeneous series of common and uncommon

cases, access to cases previously included in multicentre

and international clinical trials, access to cases included

in multicentre co-operative projects, improvement of effec-

tive multicentre connections, implication of National and

International Scientific Societies in research projects etc,

while avoiding the intrinsic bias of multi-centre studies.

Tumour Bank Networking implies standardised techni-

cal procedures, a strict and common quality control pro-

gramme, homogeneous ethic requirements and, most

importantly and frequently the most difficult to attain, an

open mentality for sharing.

The Tumour Bank Network, instigated and coordinated

by the Molecular Pathology Programme of the Spanish

National Cancer Centre (CNIO), aims to respond to this

need by promoting Tumour Banks in Spanish hospitals.

Every Spanish hospital or group of hospitals is invited to

share in a Network characterised by a cooperative dimen-

sion, homogeneous procedures for the collection, proces-

sing and storage of neoplastic and normal tissue samples,

a unified quality control programme, and a centralised coor-

dination. Associated Hospital Tumour Banks are intercon-

nected through a computer-based network but tissue

remains in the Hospital itself, so that it can continue to

play a key role in the development of the teaching and

research activities within the Hospital. At the same time,

it represents a tool for the encouragement of multi-hospital

cancer research (http://www.cnio.es/ing/programas/prog-

Tumor01.asp).

Ethics and laws

Although there are broad principles regarding the use ofhuman tissue material in Europe and the US, the variouslaws and customs in the different countries or States showthat national laws and customs still dominate.2 Occasion-ally, there are conflicts of laws and policies between thesenations and states. To bring these diverse legislationstogether is, perhaps, the most important challenge forTumour Bank Networking in the very close future.1,4,11

Europe needs a common legislation which explicitly

would cover the use for research, not only for clinical prac-

tice or genetic susceptibility studies, but also for surplus dis-

eased and normal tissue, linked histopathological data and

relevant clinical information, with a linked anonymised

design. Independent of present legislation, a common legis-

lative body should be formed for European countries, which

enables and enhances the development of international mul-

ticentre studies. A multidisciplinary approach to the pro-

blem is necessary where researchers must participate

alongside lawyers, ethical experts and representatives

from within society.4,12

References

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