Tissue Banking Overview: Washington University Medical Center

8/21/2012
ICTS Brown Bag Seminar
• Successful Completion: Participants must complete an evaluation
form to receive a certificate of completion
• Contact Hours: 1 contact hours is available to those who meet the
successful completion requirements
• Sponsorship & Commercial Support: This activity has received no
sponsorship or commercial support
• Conflict of Interest: No conflicts of interest were identified
• Non-Endorsement: Accreditation approval refers only to MONAs
continuing education activities and does not imply MONA or ANCC
Commission on Accreditation endorsement of any commercial
products
• Off Label Use: There will be no discussion of uses of products other
than what is approved by the FDA.
• Expiration: Contact Hours expire on November 17, 2013
Dr. McDonald’s Disclosure
1. Employee: Dr. McDonald receives salary
and a retirement plan from Wash U
medical school as an employee
2. Research Support: Dr. McDonald and the
tissue bank at Wash U, receive multiple
sources of internal and external grant
funding
1

8/21/2012
Tissue Procurement Facility background:
Washington University Medical Center
Sandra A. McDonald, MD
Department of Pathology and Immunology,
Washington University School of Medicine, St. Louis, Missouri
Brown Bag Lunch
Seminar Series
August 30, 2012
Summary
• Biobanking science overview
• Resources, mission, offered procedures of
biorepository, and key contacts/ URLs
• General principles of specimen ordering,
procurement, evaluation, processing, and QA
• Precautions for specimen banking
• Pathologist roles in banking
• Specimen procurement
• Digital pathology
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8/21/2012
Washington University
Medical Center
Biorepository
• A centralized resource for biospecimens and laboratory
procedures, started in 1997 as effort with Siteman Cancer Ctr.
• Laboratory for Translational Pathology /Tissue Procurement
Core) , 14 FTEs
• ~500,000 samples (tissues and biofluids) derived from a
variety of internal and external collection protocols (~70 open
currently) and clinical trials; traditional focus is neoplasia
• Collection, storage, quality assurance and scientific
utilization/impact of biospecimens, to better understand the
molecular / genomic basis of cancer and translations to pt. care
• Fee-for-service mechanism, usage on a request-driven basis
• Resource limited currently
Wash U Biorepository Workflow
Incoming
tissue,
blood ,
and other
biofluids
SAMPLE ACCESSION,
PREP & PROCESSING
Some samples
Most samples
Some samples
Investigator
requests
(samples
pulled from
storage in
response)
STORAGE
(mainly frozen
biospecimens, few
paraffin blocks)
HISTOLOGY
Some samples
Sections and/or
fresh-frozen
tissues
disbursed to
investigators
Samples disbursed to
investigators; however, for
most samples, histology
or molecular workup is
needed first (black arrows)
MOLECULAR
Make RNA & DNA
Sample flow within repository
Sample Entry Points
Sample Exit Points
Key component of repository
Molecular samples disbursed to
investigators (following isolation
and QA)
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8/21/2012
Washington University Medical Center Biorepository
WU Laboratory for Translational Pathology
Watson
(legacy director)
McDonald
(director)
Brink
(processing)
Holtschlag
(manager)
Fox
(regulatory)
Mulvihill
(informatics)
Granderson
(processing)
Henson
(processing)
DeSchryver
(pathology)
Zhang
(molecular)
Gaudin
(molecular)
Reagan
(processing)
Archer
(processing)
Cruise
(histology)
Rozycki
(molecular)
Oertwig
(processing)
Processing Histology Molecular
accessioning
storage
protocols and kits
general tumor
bank archive
tissue processing
tissue sectioning
laser
microdissection
DNA and RNA
preparation and
quality and
quantity
determinations
4

8/21/2012
BJCIH
Laboratory for Translational Pathology/
Tissue Procurement Core
Phone: 454-7605 /454-7615
Email: tbank@pathology.wustl.edu
Location: Room 2454 Kingshighway Bldg
Washington University Medical Center Biorepository
‣ Prospective procurement for research protocols
‣ Archival specimen bank
‣ Specimen processing
‣ Laser capture microdissection
‣ RNA and DNA prep and QA analysis
‣ Biospecimen informatics
‣ Pathology interpretation/ slide review
‣ Scientific consultation
‣ Consultation on informed consent, IRB
procedures
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8/21/2012
Why Use a Core Facility ?
• More efficient use of personnel, space, and resources
• Use of uniform processes and policies across all
biospecimen-related activities, including those required by
regulatory or advisory bodies
• Creates a neutral entity that can oversee the distribution and
utilization of resources in a coordinated fashion, while
appropriately protecting patient privacy
• Preserves biospecimens and associated data beyond the
tenure or legacy of individual investigators or studies
Why Bank Specimens ?
• Molecular analysis of animal models and cell lines have
limitations with regard to clinical relevance.
• Infrequent disease presentations must be collected over time.
• Aged specimens with clinical follow-up are more useful for
clinical correlative studies.
• Rare and valuable specimens should be stored and distributed
judiciously.
• Specimens and data must be quality-controlled.
• Resources are needed to initiate funded research projects.
• Basic research findings can be translated into clinical
(diagnostic) tools.
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8/21/2012
Classification of banked specimens for billing purposes
Public - is a discard from surgical pathology. Consent is either waived or, if feasible, is
obtained retroactively from the patient (i.e. at some time point following surgery) by the
research nursing coordinator for the Tissue Procurement Core. SCC supports the total
cost of procurement, deposit & storage. The investigator/study protocol requesting
withdrawal of public samples assumes the cost of withdrawal procedures.
Semi‐Public ‐ Collected per an approved research protocol. The scientist supports
the cost of protocol approval and sample procurement. The SCC supports the cost of
sample processing for deposit and storage costs. Semi‐public samples are considered
owned by both SCC and the principal investigator (PI) of the consent form. The
investigator/protocol requesting withdrawal of semi‐public sample assumes the cost of
withdrawal procedures. Sample usage not restricted to a certain investigator or group.
Private ‐ collected per an approved protocol. The PI supports the cost of protocol
approval as well as the cost of sample procurement, storage & withdrawal. A private
sample may not be withdrawn by another investigator unless the original protocol PI
agrees.
Tissue Utilization Committee
• Has been established for the Tissue Procurement Core, and
implementation is awaiting final refinements of informatics
• Committee provides an independent assessment of resource usage vs.
benefit/impact
• Need driven by Siteman Cancer Center and CAP directives
• Committee: 1 chair, 2 statisticians (ad hoc), and 9 members
drawn from Siteman Cancer Center community
• Initially, role of this committee will be to review public bank
samples; once efficient flow is established, role will expand to
semi-public and even private samples
• Committee can also help assess the appropriateness of sample disposal,
and storage demands for new protocols
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8/21/2012
Fee for service schedule
• In an effort to better meet its operational expenses, the Tissue
Procurement Core has initiated a fee-for-service schedule
• Labor, reagents/consumables, and/or infrastructure components
underlie the charges
• Fee-for-service schedule is shared with investigators when they
contact the bank for protocol initiation or sample withdrawal
• Examples of charges:
Service Unit Actual Cost
Ficoll Processing
10 ml peripheral blood or 2 ml BM or
10^7 cells $76.80
Ficoll Processing (large scale)
60 ml peripheral blood or 12 ml BM or
10^8 cells $101.78
CPT Tube Processing and Cell Freezing per tube $31.97
Cell Cryoperservation per 10^7 cells $4.28
Cell Processing and Cryopreservation
10‐20ml peripheral blood or 2‐5ml of
BM $31.67
Laser capture microscope tech time per hour $59.95
Laser capture microscope use per hour $29.95
DNA prep and QA from cell pellet per sample $17.29
Tissue Fixation and Embedding $15.91
Storage under liquid N2 vapor per stored aliquot per year $0.21
Tissue banking and clinical trials
• Is important for tissue banking, especially for
pharmacogenomics and correlative biomarker studies
Objectives:
• relate biomarkers to onset, course, and outcome of disease
and the level of response to various treatments
• predict who will respond to therapy
• modification of expression of targets/other biomarkers in
response to therapy
• future use of tissues for hypotheses not known at present
(depending on consent scope-of-use)
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8/21/2012
Specimen Collection
• Diseased Tissue
Genetic, biochemical, or histological analysis of
disease process
Sampling Site
Fixed vs. Frozen (Dictates storage needs
and future utilization)
Fixation Type
Embedding Medium
• Serum /
Plasma
Biochemical
studies
Aliquot and
freeze
• Peripheral Leukocytes/Bone Marrow
Genomic (germ line) analysis; Occult
tumor cell detection
Whole blood
Enriched nucleated cell fraction
Density gradient centrifugation
Cryopreservation / Immortalization
• CSF and
other fluids
Cytospin
Freeze
Terminology for collected/ banked samples
Identified – Labeled with personal identifiers such as name or SSN
Coded – Labeled with a clinical trial subject number, investigator has
access to the code
De-identified – Labeled with a unique second number; link between this
second number and the clinical trial subject number is maintained in a
highly secure database, and generally unavailable to investigators and
patients
Anonymized – Link described above is irreversibly removed, so that
specimens cannot be traced back to patient identities by anyone
Anonymous – Samples without personal identifiers, and whose identity
is unknown. An increasingly nebulous concept these days, with the
advent of whole exome and genome sequencing, where the data is
increasingly viewed as essentially the patient’s identity
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8/21/2012
Informed consent for general tissue
banking collection
• Specimens collected as part of routine care
• Specimens not needed for clinical management
• Bank representative may access clinical data
• May elect to be contacted for future studies
• Investigator never provided with patient identity
Online ordering system
http://pathology.wustl.edu/research/cores/ltp/request.php
• Wash U biorepository (2/2011) established a web-based specimen ordering
system
• Efficiency and tracking advantages
• Not part of caTissue Suite program
• Successful design needed consideration of lab workflow and customer needs
• “Front end” – user-initiated, password-protected ordering request form
• “Back end” – request tracking system accessible only to lab
• User enters profile, project, and request details, and then request is assigned
a number as it moves through the system
• Path of a request depends on the three major categories of provided services:
• Submit investigator's own samples for lab procedures
• Request specific sample IDs distributed directly from the repository
• Request general tissue/organ types or diseases
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8/21/2012
Advantages of
online system
• Accessibility to research community – as a link on
departmental website
• Automatic capture of required information
• Reliable documentation (what was requested, and who)
• Tracking of stage within laboratory
• Easier compliation of metrics related to requests
• Possibility of additional levels of monitoring/ review if
needed
• Status communications to requestors – through the “back
end” updating the “front end”
caTissue Suite v1.2
• Web-based application for biospecimen information management
• Professional approach to software design
• Open source / Open access (Free)
• Iterative development cycle (Always improving)
• Flexible to meet the needs of varying biobank environments
• Multiple sources of electronic and human support
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8/21/2012
Anatomic pathology correlation, including gross
and microscopic evaluation, is critical to the
success of research tissue banks.
Such correlation facilitates
• optimal sample procurement from gross
specimens, especially surgical pathology
• optimal selection and use of banked tissue
samples to meet research objectives.
McDonald SA. Principles of research tissue banking and specimen evaluation from
the pathologist's perspective. Biopreservation and Biobanking, 8: 197-201, 2010.
Tissue processing
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Specimen QA
• Specimen identity
• Important using whole genome technologies
• Histological review of tissue specimens
• Tissue viability, cellularity, disease representation
• Conflicts in diagnosis
• Molecular review of specimens
• A260/A280 and A260/A230 ratios
• Gel electrophoresis results
• Feedback to biospecimen source / collectors
Principles of specimen collection
‣Specific, reproducible criteria are the most
important, which are standardized as much as
possible across the collection sites
‣Clear, practical procedures are needed, with
good communication essential
‣Tissue bank users should understand
collection practices and how they might
impact their studies
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8/21/2012
Specimen Collection
• Dedicated personnel on call to collect biospecimens from
BJH OR, surgical pathology suite, and clinics.
• Self-contained biospecimen procurement kits and
procurement tutorials to collect off-site.
• Collection of surgically resected tissue, peripheral blood,
bone marrow, needle biopsies, and lavage fluid.
Specimen Preservation
• Snap Freezing
Difficult / Requires resources
Poor histology
Expensive storage
Best molecular yield
• Ethanol Fixation / LMPE
Difficult / Requires resources
Stability issues
Good histology
Cheap storage
Good molecular yield
• “RNALater”
Still need to freeze / embed
Poor histology
Convenient
Good nucleic acid yield
• Formalin Fixation / PE
Poor molecular yield
Standardized
Stable
Excellent histology
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8/21/2012
Specimen Storage
• Ultralow mechanical freezers (-80°C)
Cheaper (Long Term)
Error Prone
Less Stable
• Liquid nitrogen (-130°C)
More Stable
Less Error Prone
More Expensive
• Vacuum sealed (4°C)
Paraffin Blocks / Slides
No Data
Gross procurement of tissues for research banking
‣ Academic hospitals with research tissue repositories
often derive many internal specimen acquisitions from
their site's surgical pathology service
‣ Typically, such acquisitions come from appropriately
consented tissue discards sampled from surgical
resections
‣Tissue, if not banked, would otherwise be thrown
away since it is not needed for clinical diagnosis
‣ Surgical pathology has patient care as its primary
mission, so competing needs for tissue inevitable arise:
preserving adequate tissue for clinical diagnosis is key
‣ Involvement of trained pathology personnel is
important
McDonald SA, Chernock RD, Leach TA, Kahn AA, Yip JH, Rossi J, Pfeifer JD. Procurement of
human tissues for research banking in the surgical pathology laboratory: prioritization practices at
Washington University Medical Center. In press, Biopreservation and Biobanking, 2011.
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8/21/2012
Sample for
diagnostic
surgical
pathology
Yes, more tissue needed
for microscopic
diagnosis
In effect, every region
of every specimen is
subjected to a threeway
decision in the
gross room!
Option #1
Option #2
Sample for
tissue banking
(general or
specific
protocol)
More for
banking
(rare, since
tissue is fixed
at this point)
Is more
tissue now
needed for
diagnosis?
No
Option #3
Do neither
Specimen goes into
formalin; kept for a
short time following
diagnostic signout
Surgical biospecimens are often inadequate for
molecular diagnostics
• Many diseases and cases are not subject to surgical
therapy
• Many diseases and cases are not treatment naïve at the
time of surgical therapy
• Surgical therapy often occurs at only one time point in
a patient’s clinical course
• Surgical specimens experience tremendous preanalytical
processing variability
• Competing needs for traditional histopathology
assessment
• Requirement for minimally invasive, repeated sampling
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8/21/2012
Tissue banking
principles
‣ Changes made recently to surgical tissue collection/
transport practices which result in delivery of more
tissue in “real time” (

8/21/2012
Laser capture microscopy
Before LCM After LCM Cap picture
Adenocarcinom
a
Digital
pathology
‣ Biorepository has access to an Aperio XT
120-slide digital slide scanner within pathology
department
‣ Useful for slide review and sharing,
documentation, teaching
‣ Image analysis programs hold promise for the
quantitative assessment of cases, especially
tumor % cellularity
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Acknowledgments
• Siteman Cancer Center (Grant #P30 CA91842)
• Institute for Clinical and Translational Science
(Grant #UL1RR024992)
at Washington University Medical Center,
which have partially funded the biorepository at
Washington University School of Medicine.
• Mark Watson (co-director, LTP)
• Vicky Holtschlag (lab manager, LTP)
• Benjamin Ryan (IT)
• All my LTP colleagues!
Backup slides
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8/21/2012
Suitability of Needle Aspirates for Molecular
Diagnosis of Lung Cancer
• Lung adenocarcinoma is often
non-operable
• Diagnosis is limited to FNA or
Needle Core biopsy
• Sampling quality depends on
modality
• Sampling quality is operator
dependent
• Requires QA for overall sample
quality and representation
Sample Set
• 17 resected tumors > 17 RNA
• 17 resected normal > 17 RNA
• 17 (matched)ex-vivo FNA > 10 RNA
• 29 in-vivo FNA > 8 RNA
• 4 image-guided
• 4 endoscopy
92 gene
predictor
Lim, Clin. Ca. Res.
9;5980 (2003)
Building a WU Repository Network
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8/21/2012
WUMC Biobanking 2011
Regulatory Requirements
• For biospecimen procurement, risks are mainly breach of confidentiality.
• HIPAA: (45 CFR Parts 160 and 164) Conditions under which PHI may be
used or disclosed by Covered Entities for research purposes:
• “Safe Harbor” method: Lists 18 specific types of data elements that
must be removed; de-identified data does not constitute PHI and
therefore can be freely disclosed.
• Statistical method.
• The “limited data set”: Requires removal of 16 elements and an
agreement to be executed limiting the use of the data
• Requirements of individual institutions / IRBs
• FDA Rule for Human Subjects Research (21 CFR Part 50)
• State law
• Intellectual Property / Materials Transfer / Legal Requirements
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Contraindications to tissue banking
‣ small tumors and other cases where most
lesional tissue is needed for diagnosis
‣ surgical margins of resection
‣ specimens where tumor and benign areas
cannot be clearly delineated grossly
‣ grossly visible areas of primarily necrosis,
hemorrhage, or fat
‣ specimens which are known to have been
delayed significantly more than 30
minutes past their procurement time in the
OR
‣ tissue previously freeze-thawed, or frozen
slowly (e.g. in the cryostat or -80 freezer)
Contraindications to tissue banking
‣ areas of deepest invasion, tumor/normal
interface, tumor/capsule interface,
extranodal extension of tumor, and
other key landmarks for surgical
pathology evaluation and tumor staging
‣ chemotherapy- or radiation-treated
tumors with no gross residual tumor
mass
‣ diagnostic biopsies where most or all
tissue must be submitted for pathology
evaluation…most lymph node, GI,
bone marrow, and liver biopsies
fall in this category
‣ tissue clearly marked as intended
for a special study such as
immunofluorescence
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8/21/2012
Organ-specific contraindications: examples
• Too little tissue typically available for banking, or all
available tissue often needed for diagnosis
– Brain tumors
– Testicular tumors, especially germ cell neoplasms
– Many diagnostic biopsies
– Primary melanomas
• Diagnoses where submission of most or all tissue is
needed to substantiate a previous diagnosis or look
for invasive areas
– DCIS, LCIS, atypical endometrial hyperplasia
Organ-specific contraindications: examples
• Necessity to preserve landmarks important for
surgical pathology evaluation
– Capsule for thyroid masses
– Surgical margins
– Stalk for tubulovillous adenomas
– Lymph node capsule in radical neck dissections
• Gross/ microscopic correlation difficulties
• Bony tumors requiring decalcification
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8/21/2012
Organ-specific contraindications: examples
• Necessity to preserve landmarks important for
surgical pathology evaluation
– Capsule for thyroid masses
– Surgical margins
– Stalk for tubulovillous adenomas
– Lymph node capsule in radical neck dissections
• Gross/ microscopic correlation difficulties
• Bony tumors requiring decalcification
Key issues for banked samples:
our experience
‣samples received from outside sources may not be
of the type or disease state advertised, or may be of
poor quality, i.e. necrotic
‣certain cell types within a sample, such as epithelial
lining or an inflammatory component, may need to
be isolated specifically, rather than the whole tissue
being digested in an expression assay
‣pigments, inflammatory infiltrates, preservation
conditions, or other features may affect the intended
performance of the tissue in an expression assay.
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8/21/2012
Sampling issues
This sample of metastatic
adenocarcinoma in the liver is largely
necrotic. Therefore, this would not be
an ideal specimen for most studies,
especially digestion of the tissue for
RNA expression studies (H&E, 200x)
The endometrial glands of this uterus
specimen are of primary interest, but
the specimen also contains stromal and
vascular cells. Thus, specific isolation
of the desired cell type may be needed,
for example through laser-capture
microscopy, if a digestive assay is
planned (H&E, 400x)
Contributions of tissue banking
Demonstration by IHC that a
phosphorylated membrane
receptor was overexpressed in
human lung carcinoma (brown
reaction product) helped support
research interest in the receptor
(200x)
Identification of respiratory
epithelium (top) was needed for its
isolation by laser capture
microscopy, to perform pilot
studies for gene expression in
diseased lung tissue (H&E, 400x)
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8/21/2012
“Adjacent normal” tissue
This case of
metastatic carcinoma
to the liver showed
inflammatory
infiltrates in portal
tracts in the adjacent
non-neoplastic liver
tissue
Discrepancies between stated and actual
specimen dx: commercial samples
• This specimen was
billed by a commercial
tissue provider as
normal lung (H&E,
200x)
• This specimen was
billed by a commercial
tissue provider as
normal pancreas (H&E,
200x)
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8/21/2012
Lessons learned
When planning the use of tissue specimens
in research, think like a pathologist and
consider how gross, histologic, and quality
factors in the tissue may impact your studies
“Trust but verify” – be suspicious of any
diagnosis or interpretation attached to an
outside tissue, unless you have examined it
histologically
Pathologists and tissue microarrays (TMAs)
• Tissue arrays provide rapid screening for dozens
or hundreds of tissue specimens with probes for
protein, RNA or DNA targets, without exhausting
tissue resources.
• Traditional TMA = paraffin block
• TMAs adaptable to any assay routinely done on
tissue sections
• Multiorgan TMAs and matching tumor/normal
TMAs enhance the output of information
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8/21/2012
Tissue Microarrays
Advantages
High-throughput screening (100-500 cases per slide)
Uniform processing across all cases
Conservation of specimen block
Conservation of probe (antibody)
Adaptability to image analysis programs for interpretation
Disadvantages
Limited sampling of specimen
Low-throughput interpretation
Need for robust informatics
Tissue microarray construction
TMA work
station. Cores
of tissue are
transferred
from donor
blocks to the
arrayed
recipient block.
The arrayed
slides can be
stained by IHC,
ISH or FISH.
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Pathologist roles in TMAs
Selecting “donor”
tissue blocks for
TMA construction
Selecting areas of
“donor” blocks to
obtain tissue core from
Configuring TMA block
parameters appropriately.
For example, too many
cores on a slide will yield
smaller core areas. This
raises the risk that edge
artifacts from IHC staining
will obscure useful
information.
Reviewing H&E slide
for TMA blocks, for
quality assurance
purposes (i.e. making
sure that appropriate
tissues are represented in
cores, and documenting
if they are not)
Operating Procedures for Specimen Evaluation
Verify the pathology of all incoming tissues,
storage of these interpretations in data files
Communicate with outside tissue suppliers about our findings
and any discrepancies with claimed diagnosis or tissue quality
Consider the project goals and methods vs. the anatomic
makeup of the tissue:
What cells or component(s) of the tissue are key to the
study or the choice of controls?
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8/21/2012
Operating Procedures for Specimen Evaluation
Supply H&E sections matching
the provided tissue, with relevant
areas of disease marked
Oncology: areas of tumor,
pre-malignant change,
normal adjacent tissue,
overall % tumor cellularity
Atherosclerosis: areas of
plaque (stable and
unstable) vs. normal
vessel wall
Collection Limitations
• Surgically Inaccessible
Previous resection
Brain metastasis
Small cell lung cancer
• Limiting Material
FNA
DCIS
• Sampling Error
Prostate cancer
• Proper Collection Procedures
Primary hospitals
Academic centers
• Insufficient Claim / Interest
• Competition
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8/21/2012
Solutions
• Specific Protocols for Prospective Procurement
Need Clinician Interest
Need for Informed Consent
• Use of Archived Surgical Pathology Clinical Specimens
Inability to Obtain Informed Consent
Technical Hurdles
• Use of Smaller Specimens (FNA / Touch Prep / Histological
Sections)
Need Clinician Interest
Technical Hurdles
• Education and Support
‣ Only tissue that is absolutely not needed for clinical
diagnosis should be collected for the Tumor Bank. If in
doubt, do NOT submit specimens for banking.
‣ Once specimens have been accessioned into the Bank, they
cannot be used for clinical purposes.
‣ Procurement practices are a “work in progress”, i.e. can and
should be changed in response to evolving needs
‣ Specialized protocols exist (LCBRN, TCGA); surgical and
TPC staff will assist with these
‣ Questions regarding tissue banking procedures:
– Sandra McDonald (7-5773)
– Joan Rossi (2-0135)
– Tracey Leach (7-1354)
– Tissue Procurement Core (TPC) processing lab (4-7615)
(Amy Brink, Vicky Holtschlag)
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General procedure
‣ Use a Tissue Procurement Specimen Bag – these contain a white-label area with a
TPC-provided number written on them. Do not use any other container or bag. If
no bags are available call the TPC (4-7615) to obtain more bags.
‣ Check the specimen submission sheet from the OR and verify that the specimen is
acceptable for tissue banking (i.e. the specimen is not marked for special studies
such as immunofluorescence requiring immersion in special fixatives).
‣ Fill out the patient information on the sheet titled "Tumor Bank Tissue Collection"
which is located next to the cryobath. On the left-hand side of this sheet, place the
patient information. Important: include the surgical pathology number here. On
the right-hand side, place the bag's number, tissue type, and "collected by" person
(pathologist or PA who actually procured the banking specimen)
‣ Do not label the TPC bag with any patient or clinical information; instead place
that on the sheet.
General procedure,
continued
‣ Place a single tissue specimen flat in the plastic bag. A single tissue specimen's volume
should be at least 0.5 cm 3 , and at most 3 – 4 cm 3 , with at least one dimension measuring
< 0.5cm thick for quick freezing.
‣ Collect non-malignant and malignant tissue. Non-malignant (i.e. "adjacent normal") tissue
should be collected > 2 cm from the primary tumor, subject to any geometric limitations.
Do not place tumor and non-malignant tissue in the same bag.
‣ If feasible, collect and separately identify both: 1) primary tumor and 2) metastatic lesions to
lymph nodes or other tissues.
‣ 5-7mm skin punch biopsy instrument can be considered, instead of a scalpel blade, as a way
to get samples fromdifficult cases
‣ TPC's 2-methylbutane bath (-50C) immediately afterwards
‣ Goal: bankable tissue immersed in bath

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caTissue: Event / QC Tracking
caTissue: Specimen Search
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caTissue: Search Results
Tree view of results
Results table view
with pre-defined
data elements
Select specimens
for request
Building a WU Repository Network
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Clinical tissue banking:
Requirements for a successful program
‣ Close partnerships between pathologists, surgeons, and
hospital adminstrators
‣ Demonstration of solid clinical value to hospital
administration
‣ Pathologists’ assistants and other gross room staff with
good knowledge of gross room techniques
‣ Knowledgeable tissue bank pathologist(s) and staff who
understand the process and the value of good communication
‣ Transport personnel between operating rooms and
pathology laboratory
‣ Instruction/ education process for staff and stakeholders
Research vs. clinical tissue banking
• In the past, tissue banking was regarded as primarily a research activity
• Advent of molecular technologies has made the storage of fresh-frozen
tissue for diagnostic purposes desirable; i.e. tissue banking can and
should become a routine part of patient care
- Specimens banked now and used later at an unspecified time
- Results may be correlated with past or future clinical specimens,
i.e. time becomes an added dimension of banking, especially
advancing knowledge/ hypotheses
• Consent and IRB expectations for clinical tissue banking should evolve
similarly to other clinical processes, i.e. clinicians not needing specific
IRB approval for diagnostic blood draws from patients
- Clinical bank specimens would remain identified
• In a sense, clinical tissue banking has always existed with paraffin block
archives from surgical pathology; demand for fresh-frozen specimens
driven by molecular/ genomic technologies is key
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8/21/2012
Comparison between umbilical cord blood banking and clinical
tissue banking
Issue Comparison Comments
Time dimension of the
biobanking process
Promotion of advantages of
the procedure to physicians
and patients
Link to patient identity
Accreditation
In both fields, specimens are
banked now for an uncertain but
potentially high-impact use in the
future; can be of benefit in ways
not necessarily forseen at the
time of procurement
Communication/education is a
central component of cord blood
banking to increase use of the
procedure; this is also likely true
of clinical tissue banking
Private (though not public) cord
bank specimens linked to patient
identity; required for clinical
tissue banking
Besides FDA regulations, the
American Association of Blood
Banks (AABB), (CAP) and the
Foundation for the Accreditation
of Cellular Therapy (FACT).
Accreditation program for tissue
banks (CAP) released in 2011.
Education of users is required,
since stakeholders often tend to
value only those things that offer
immediate benefits
Helps overcome expectation and
cost barriers, and helps the
practice become more widely
used
Consent process distinct from
that that used for biospecimen
repositories focused on research
Certification standards and
accreditation programs enhance
patient care; they will also
increase patient and physician
confidence in the overall
enterprise, as well as the
individual repositories they use
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