“Biobanks: a tool for research
in the 21st century”
Experience of Tumour Banks in Portugal
Fátima Carneiro
Coordinator of the National Network
Tumour Bank Project
Tumour Bank – General principles
Aim of a Tumour Bank: to acquire neoplastic and control non-neoplastic
material of tumours, in the form of tissue fixed in formalin and paraffin
embedded, of samples that are unfixed or frozen according to conventional
methods and even as fresh tissue.
Excess of tissue: in no case may the correct diagnosis of a sample be
compromised by reason of the collection of material for the Tumour Bank.
Only excess tissue can be collected.
Informed consent: patient’s approve that surplus tissue remaining following
its use for correct histopathological diagnosis may be used for research
purposes, safeguarding the principle of confidentiality and Data Protection
Law.
Ethical Committee approval: approve of general principles and, if necessary,
the whole project.
No profit activity
Role of pathologists in Biobanking (Tumour Banking)
Recognize the central role of pathologists in a
multidisciplinary team
The role of pathologists is central to tumor banks. This does not mean that the
pathologist ought to be the chairperson of the biobank, but it is also true that
there cannot be a tumor bank without a pathologist. The pathologist is involved
in the following central activities in the tumor bank:
• Organizing the logistics of tumor samples between the operating room and
Pathology Department
• Deciding which specimens need to be sampled
• Sampling the tumor, provided that there is enough tumor left for diagnostic
purposes
• Sampling the normal counterpart tissue if available
• Morphological control of sampled tissue-cells, to ensure samples are
representative.
• Quality control of stored tissue.
• ...
Fátima Carneiro & Enrique De Alava Casado
How did we begin?
Questionnaire on major European bio-banking
initiatives for cancer research
For each bio-banking initiative, please specify and give figures where appropriate :
• geographical location
• type of bio-bank (university-driven, private, public or other)
• whether they are part of a national, European or international network
• the purpose of the bio-bank (diagnostic, therapeutic, population-based or for tumourspecific research etc)
• the sources and amount of funding
• type of sample (blood, biofluids, nucleic acids, solid tumours…)
• approximate number of stored samples and their type of conservation (fresh-frozen
tumours, paraffin-embedded…)
• the type of clinical annotation of samples (patient treatment and follow-up data)
• whether they are virtual, real or both
• the informatics used by the banks
• their website address if appropriate
European Alliance Against Cancer
National Survey on Tumour Banks in Portugal
• Organized by Coordenação Nacional para as Doenças Oncológicas
(President – Dr Joaquim Gouveia)
• Number of Hospitals/Research Institutions surveyed
86
• Number of returned questionnaires
62
• Number of Tumour Banks available or in the way of being established
10
Portuguese Institutions with Tumour Banks
Banks already legalized
H.S.João - Porto
IPATIMUP – Porto
University Hospital of Coimbra
Hospital Garcia de Orta – Almada
Department of Pathology
Department of Pathology
Department of Pathology
Department of Pathology
Banks in the way of being established
Portuguese Institute of Oncology – Porto
Portuguese Institute of Oncology – Coimbra
Portuguese Institute of Oncology – Lisbon
Inst. Molecular Medicine/H.Sta Maria – Lisbon
Department of Pathology
Department of Pathology
Department of Pathology
IMM/H.Sta Maria (Dep Pathol)
Observers
INSA – Lisbon
H.S.João - Porto
INSA
Clinical Haematology
Minimal requirements for the
establishment of a Tumour Bank
• Staff (pathologist(s); technician(s); full/part time)
• Legal/ethical (informed consent; legalized data base)
•Technical (equipment; protocols for sampling, freezing
and storing)
• Quality control
REQUISITOS MÍNIMOS PARA O ESTABELECIMENTO DE UM BANCO DE TUMORES
Um Banco de Tumores (BT) é um repositório organizado de amostras de tumores (neoplasias), podendo compreender tecidos não-neoplásicos.
As amostras arquivadas no BT podem ser constituídas por fragmentos, células e/ou líquidos ou seus derivados (DNA, RNA, proteínas),
independentemente do tipo de preservação das amostras biológicas (fixação, inclusão em parafina, congelação). A finalidade do Banco de
Tumores é arquivar material em condições ideais para investigação biomédica, podendo ser um local de depósito temporário de amostras
susceptíveis de serem utilizadas para diagnóstico, avaliação de factores de prognóstico ou identificação de alvos terapêuticos. A
disponibilidade deste tipo de material, recolhido em condições óptimas, permite o desenvolvimento de investigação de translação e a aplicação
dos conhecimentos da investigação biomédica básica a problemas clínicos relevantes.
Qualquer BT exige a participação activa de anátomo-patologista(s) a quem cabe um papel crucial na identificação, colheita e controlo
morfológico das amostras
http://www.acs.min-saude.pt/wp-content/uploads/2008/01/requisitos_bancotumores.pdf
Banks in the way of being established
Ethical approval
Approval by ACSS Legalized Data Base
(informed consent)
Portuguese Institute of Oncology – Porto
Yes
No
No
Portuguese Institute of Oncology – Coimbra
Yes
Pending
Pending
Portuguese Institute of Oncology – Lisbon
?
?
?
Inst. Molecular Medicine/H.Sta Maria – Lisbon
?
?
?
The experience of the Department of
Pathology of H.S.João (Porto)
Marta Rodrigues, Joel Paiva, Isabel Vitó,
Raquel Santos, Patrícia Pontes,
Paula Silva, Fátima Carneiro
Steps followed for the establishment
of the Tumour Bank
H.S.João - Porto
• Application to “Programa Operacional PRAXIS XXI”
• Funding - 188 022,0 € (PRAXIS XXI - 75% & Hospital - 25%)
•Approval by Ethical Commission of H.S.João (including Informed Consent )
• Data base (legalized by “Comissão Nacional de Protecção de Bases de Dados”)
Informed consent
Photografy
Collection of samples
Collection of “twin” samples
Gross examination and “inking”
Freezing
Storage (frozen and FFPE samples)
1
2
3
1
2
3
4
5
1
2
3
1
4
2
1
3
2
2
4
4
Data base
I. Identification data
Local case code
Date of birth
Gender
II. Pathology Data
Date of anatomogical and pathological study
Anatomical location of neoplastic process
Complete pathological diagnosis
Stage (pTNM etc.)
Sample type (biopsy, autopsy material, etc.)
Material available and localization in the freezer
Laser microdissection
Virtual Bank
Tumour Bank – H. S. João (Porto)
Institution (Department)
H.S.João – Porto (Department of Pathology)
Funding (Installation)
PRAXIS XXI - 75% & H.S.João - 25%
Running costs
H.S.João & Novartis Oncologia
Stored samples
Type
Number
Conservation
Solid tumours and non-neoplastic tissue
1 808 cases (4081 frozen samples)
Fresh-frozen & Paraffin-embedded
Informed consent
YES (72%)
Data base (legalized)
YES
The experience of the
HUCs (Coimbra)
ACIMAGO
Steps followed for the establishment
of the Tumour Bank
HUCs - Coimbra
• Approval by “Direcção Nacional de Saúde”
• Approval by Ethical Commission (including Informed Consent)
• Data base (legalized by “Comissão Nacional de Protecção de
Bases de Dados”)
Reception (immediately after surgery
Collection of samples
Freezing
Storage of frozen samples
Storage of paraffin embedded samples (blocks & slides)
Tumour Bank – HUCs (Coimbra)
Institution (Department)
Stored samples
Type
Number
Conservation
HUCs - Coimbra (Department of Pathology)
Tumour samples: breast, uterus & annexes, vulva
Blood, plasma, mononucleated cells
309 cases
Fresh-frozen & Paraffin-embedded
Informed consent
YES (complete – 46%; incomplete – 26%)
Data base (legalized)
YES
Quality control
The experience of IPATIMUP (Porto)
ReGENE
• Neuroendocrine Tumours
(n= 60)
ReGIST
• GISTs
(n=13)
National Network
The experience of
Hospital Garcia de Orta (Almada)
Steps followed for the establishment
of the Tumour Bank
Hospital Garcia de Orta (Almada)
• Approval by “Direcção Nacional de Saúde”
• Approval by Ethical Commission (including Informed Consent)
• Data base (legalized by “Comissão Nacional de Protecção de
Bases de Dados”) - 2008
• Establishment of strategy for development
Perspectives
Establishment of a National
(Portuguese) Network
of Tumour Banks
Requirements
• Staff
• Standard Operating Procedures
• Data Base/informatic applicatio
• Quality Control
• Virtual Bank
•…
Role of pathologists in Biobanking (Tumour Banking)
Specific attention to the training of pathologists
Pathology is an endangered species. There is a shortage of pathologists in
many Western European countries.
It is a priority to emphasize the central role that pathologists play in
translational research, specifically in tumor banking, by the establishment of a
bridge between clinicians and basic researchers.
This role is hampered by excessive routine diagnostic workload, absence of
research career/opportunities in many public hospitals, and inadequate
undergraduate/residency learning/training. The latter may have a dramatic
impact in the triggering of new ‘vocations’ for Pathology, and/or in the
involvement of pathologists in translational research/tumor banking.
Particular attention has to be given to training of Pathology residents and
continuous education of pathologists, encompassing a strong background in
cellular and molecular basis of disease, basic/advanced methodology for
research, and basics on how to apply for research funding.
Fátima Carneiro & Enrique De Alava Casado