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French tumor banks a national challenge for
health care and research. Anne Janin Pathology
Hopital Saint Louis U 728 Inserm/ Université
Paris 7 Cancéropole Ile de France
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• Why is it a challenge?
• Human tumor samples are precious
• for patientscare
• for research programs

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Why is it a challenge? 2. Human tumor
samples are in
limited quantity more care and research
needs less material available
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Less material available Early
detection smaller tumours Increased use of
needle biopsies for
diagnosis Treatment changes cancer cells
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Why is it a challenge? 3. Human tumor
samples are difficult to prepare
to store on the long term to transform
to transfer
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Two technical  bottlenecks 
prevention of RNA degradation quantification
of molecules extracted from a tumor
sample
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The answer 1. a set of rules for
operational practice established by
professionals labelized by the national
agency for accreditation in health (ANAES) in
2000 required to get national funds
evolving to rules for certification
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The answer 2. a software for tum bank
management Tumorotek chart
established by professionals realized on
national funds assessed by a jury of
industrials best application object web
2005
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The answer 2. a software Tumorotek
free disposal for public hospitals a
national group of users two informaticians
for evolution one technician for
training nicolas.malservet_at_sls.aphp.fr
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The answer 3. a network of tumor
banks set of data to be exchanged
established by professionals legal
issues on patientsdata network of the
software ongoing pb of material transfer
agreement
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Legal issues Human tumor samples
are initially taken for diagnosis and
have to be requalified for research
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Legal issues Lois bioéthiques 1994 for
persons included in a research
project Institutional review board Written
informed consent of the person Only for a
precise research program
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Legal issues Revision in August 2004
for surgical pieces only information of
the patient (rule not applied if germinal
cells)
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Legal issues Set of practice
recommandations part of the tumor should be
preserved for the patients care
sharing tumor samples by giving
limited quantity of sections,or RNA use of
MTA no exclusivity on any collection
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Who is in charge? Hospitals accredited for
cancer care Tumor samples are part
of the patients files
The priority is
to establish the
diagnosis
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Who is in funding? ministry of
education and research ministry of
health charities some industries
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The national plan for cancer
Canceropoles
regional research programs Institut
national du cancer (INCa) 2006 priorities
kidney and lung
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Economic issues some cost recovery plan
for preparation of the sample storage
tracability, duplication quantification and
distribution no clear business plan to date
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OECD task force
for biological resource
centers chairman Louis J Rechaussat rechaussa
t_at_auteuil.inserm.fr Vegetal, bacterial and
human resources Quality control regulations
Process of accreditation http//www.oecd.org
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Conclusions of the 1st report

• Establish national BRCs
• Develop a certification system for BRCs based on
  international criteria
• Create international BRCs linkages
• Co-ordinate standards, rules and regulations
  taking BRCs into account
• Establish a global BRC network

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National Certification System

• Process approved by national governments through
• a certification body recognised by government
• or a transparent certification procedure
  recognised by government
• or directly by government.
• Governments should ensure that certification body
  is independent
  has no conflict of
  interest with the BRC

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General Requirements

• CONTENT
• Definitions
• Organisational requirements
• Equipment
• Documentation management
• Informatics
• Preparation of media and reagents
• Accession of deposits to the BRC
• Preservation and maintenance
• Quality audit and quality review

Published Jan. 2004
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