Upload
manuel-m-morente
View
212
Download
0
Embed Size (px)
Citation preview
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
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
1. Cambon-Thomsen A. The social and ethical issues of
post-genomic human biobanks. Nat Rev Genet 2004; 5:
866–873.
2. Oosterhuis JW, Coebergh JW, van Veen EB. Tumour banks: well-
guarded treasures in the interest of patients. Nat Rev Cancer
2003; 3: 73–77.
3. Cambon-Thomsen A, Ducournau P, Gourraud P-A, Pontille D.
Biobanks for genomics and genomics for biobanks. Comp Funct
Genom 2003; 4: 628–634.
4. Mounier F. International Tissue Research: the challenges. Eur J
Cancer 2005; 41: 1497.
5. Adam D. Online tumour bank aims to offer ready route to tissues.
Nature 2002; 416: 464.
6. Nurse P, Pattison J, Radda G, O’Toole L. Cancer research: joint
planning for the future. Annals of Oncology 2003; 14: 1593–
1594.
7. Spanish National Tumour Bank Network. (http://www.cnio.es/
ing/programas/progTumor01.asp).
8. Gaffney EF, Flanagan C. The cancer biobank network: essential
Infrastructure for basic and clinical translational research in
Ireland. Cell Preserv Technol 2005; 3: 126–127.
Hematol Oncol 2005; 23: 54–56
Human tumour bank 55
9. Teodorovic I, Therasse P, Spatz A, Isabelle M, Oosterhuis W.
Human tissue research: EORTC recommendations on its
practical consequences. Eur J Cancer 2003; 16: 2256–2263.
10. Riegman PHJ, Oomen MHA, Dinjens WNM, et al. Tumour
tissue collection in europe. Cell Preserv Technol 2005; 3:
128–129.
11. Van Veen EB. A possible solution for the exchange of tissue
for research between centres to which different regulations
apply: self-regulation and coordinating principles. Cell Preserv
Technol 2005; 3: 130.
12. Morente M. Tissue banks: who decides what is ethical?. Eur J
Cancer 2004; 40: 5.
56 M. M. Morente et al
Hematol Oncol 2005; 23: 54–56