Tissue Resources

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Developing a Tissue Repository PART II The Nuts
and Bolts of Operating a Human Tissue Repository
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Presented by
William E. Grizzle, MD, PhD Katherine C. Sexton,
MBA THE UNIVERSITY OF ALABAMA AT BIRMINGHAM
Tissue Collection and Banking Facility
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Developing a Tissue Repository

• UAB TISSUE COLLECTION AND BANKING FACILITY
• Cancer Center Tissue Procurement Core Facility
• Southern Division of Cooperative Human Tissue
• Network (CHTN)
• SPORE Repositories (Breast, Ovarian,
  Pancreatic)
• Skin Disease Research Center
• Pulmonary Arterial Hypertension Collection
• Processing Facility
• DOD Neurofibromatosis Consortium Repository

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Developing a Tissue Repository

• PART II
• The Nuts and Bolts of Operating a Human Tissue
  Repository

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Developing a Tissue Repository

• What types of tissues/samples will your
  repository target?

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Developing a Tissue Repository

• Investigator Eligibility
• Application
• Disease Process Limitations
• Research Information/Abstract
• IRB Approval
• Commercial use
• Agreements/Acknowledgements
• Approval Process

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Investigator Eligibility

• Investigator Priority
• Tissue Utilization Committee
• Establish a Priority System/Rating
• Rotating Priority
• Emergency Needs
• Other Resources

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Investigator Eligibility

• Protocol Requirements
• Prospective Collection (Up front requirements)
• Banking Operation (Matching game)
• Details of tissue specimens needed

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Investigator Eligibility

• Agreements/Acknowledgements
• Acknowledgments in publications
• Biohazards
• Commercialization clause
• Patient confidentiality
• Indemnification
• Transfer of samples to third party

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Developing a Tissue Repository

• What details must be defined by the researcher
  for specimen collection?
• Specimen site requested (e.g. breast, colon,
  serum)
• Specimen type requested
• Malignant (1o, mets, either, both?)
• Normal/Uninvolved (tumor pt, non-tumor, other?)
• Benign (specify)
• Diseased (specify)
• Fluids (what kinds and circumstances?)
• Matches of above (required or if available?)

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Details to be defined by researcher

• Specimen size requested
• - Minimum to maximum size/weight
• Source of procurement
• Surgery
• Autopsy
• Either

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Details to be defined by researcher

• Time constraints requested
• Interval between surgery and processing
• Any? Or is time constraint not applicable?
• Autopsy hours post mortem designation

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Details to be defined by researcher

• Preparation requested
• Fresh, frozen, fixed?
• Details of preparation
• Combination of preparations?
• Information requested/required
• Review and feedback to researcher

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Developing a Tissue Repository

• What details must be defined by the Repository?
• Consent
• - Are you going to obtain consent? (IRB
  determination)
• - Which patients are you going to consent?
• - Who is going to consent?
• - Where are you going to consent?
• - When are you going to consent?
• - How are you going to track consent
  decisions?

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Details to be defined by repository

• Specimen Sources for Clinical Remnant Material
• - Surgical
• - Autopsy
• - Clinical Laboratory (Fluids)
• - Organ Donor Organizations
• - Fetal (Autopsy, Abortions, Donations)

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Details to be defined by repository

• Specimen Sources for Direct Donations
• - Fluids
• - Biopsies
• - Directed Donations
• - Research Protocol Remnants
• - Fine Needle Aspiration

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Details to be defined by repository

• Patient Information Documented
• Access to Information
• (given resources and HIPAA constraints)
• Patient characteristics
• History
• Prior therapy
• Neo-adjuvant therapy
• Follow-up

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Details to be defined by repository

• Specimen Transport
• From OR to Surgical Pathology
• From Surgical Pathology to Procurement Facility
• From Procurement Facility to Researcher

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Details to be defined by repository

• Specimen Preparation
• Fresh (stock media and additives)
• Sterility
• Frozen (Snap Frozen, OCT)
• Fixed (types of fixative, paraffin blocks,
  slides)
• Tissue Arrays
• Touch Preps
• Fine Needle Aspiration

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Details to be defined by repository

• Specimen Labeling and Identification
• Bar-coding
• ID
• Specimen description
• Patient age/race/sex
• Assignment
• Date of collection
• Other

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Details to be defined by repository

• Specimen Storage
• -80oC/-170oC
• Liquid Nitrogen
• Wet Ice/Refrigeration
• Room temperature
• Media
• Fixatives
• Slides

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Details to be defined by repository

• Storage Monitoring
• Temperature
• Liquid Nitrogen utilization
• Nitrogen monitoring
• Periodic verification of specimen storage

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Developing a Tissue Repository

• What histology services might be provided?
• Paraffin blocks
• HE and unstained slides
• Frozen sections
• Touch preps
• Special stains
• Thick sections for RNA/DNA/Protein
• Ribbons
• Tissue Arrays

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Developing a Tissue Repository

• Request Lists How could they be organized?
• Surgical Requests
• Autopsy Requests
• Pediatric Requests
• Subcontract/Off-site Requests
• Paraffin Block Requests
• Clinical Laboratory Specimens

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Developing a Tissue Repository

• Ideas for Organization of Requests
• Alphabetically by tissue site
• By size/requirement subcategory
• For autopsy, by site, then HPM
• By preparation

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Developing a Tissue Repository

• How will I know about the potential cases that
  might yield tissue for research?
• Access to surgical schedules
• Communication with autopsy personnel
• Access to hospital on-line records
• Collaboration with clinical protocols

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Developing a Tissue Repository

• How do I actually get access to the specimen?
• Specimen containers to the OR
• Personnel stationed in the OR
• Personnel stationed in FS room
• Personnel stationed in SP gross room
• Personnel attend the autopsy

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Developing a Tissue Repository

• How do I get the remnant tissue for research and
  what do I do with it?
• Communicate to SP personnel what type of remnant
  tissue is needed
• Place tissue in cold saline, or other transport
  media
• Transport to processing lab on wet ice
• Process in Surgical Pathology gross room
• Place tissue to be frozen on dry ice or in dewar

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Developing a Tissue Repository

• How might I keep track of cases?
• History Sheets
• - Required info age, race, sex
• - Additional info smoking, drinking
• history, prior treatment
• - Family History
• - Bucket control

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Developing a Tissue Repository

• What Space and Resources will I need to begin?
• Space
• Personnel
• Equipment
• Resources

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Resources needed

• Space
• Size
• Location (convenient to tissue sources?)
• Safety Issues
• - Ventilation
• - Floors

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Resources needed

• Personnel
• Responsibilities
• - Collection - Shipping
• - Processing - Data Entry
• - Budgets/Billing - Prep of Reports
• - Communication - Grant writing
• Hours of operation of facility/On-call
• Resources

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Resources needed

• Laboratory Equipment
• Storage equipment
• - Freezers (LN2, -80o)
• - Monitoring
• - Refrigerators
• - Block slide storage
• Ice machine
• Autoclave
• Hood

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Resources needed

• Histology
• Cryostat
• Microtome
• Tissue Processor
• Embedding Center
• Waterbath
• Oven
• Tissue Array System

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Resources needed

• Administrative Equipment
• Computer/Printer
• Telephone/Answering Machine Pagers/Cell phones
• Copy machine and facsimile
• File cabinets and office furniture

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Resources needed

• Supplies
• Liquid nitrogen
• Surgical instruments
• Collection containers
• Media/Serum/Additives
• Autoclave supplies
• Sample storage
• Histology supplies
• Administrative supplies

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Developing a Tissue Repository

• Computerization/Information Processing
• Goals
• Size of operations
• Patient confidentiality
• Output requirements
• Input effort
• Sharing data/Common Data Elements/CaBIG
• Use of existing customized/off shelf programs

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Developing a Tissue Repository

• What information should be documented?
• Depends upon needs of investigator
• Depends upon goals of repository
• Lead specimens
• Silver specimens
• Gold specimens
• Platinum specimens (most extensive)

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Information to document goals of repository

• Platinum Specimens (most extensive)
• - Collection parameters (e.g. warm ischemia
  time)
• - Processing parameters and individual times
• - Exact chain of custody
• - Detailed patient information

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Developing a Tissue Repository

• Expectations for your Repository
• 3-5 years of insufficient requests
• Investigators begin to use facility
• Collection of prelim data for grant preparation
• Recognition of stable and reliable tissue source
• Followed by 3-7 years of exponential growth
• Investigators now rely on facility
• Grants requiring tissues have been funded
• Requests for tissue referred to facility

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Developing a Tissue Repository

• Questions
• Case Studies
• Discussion
• What has been your experience in establishing a
  Human Tissue Repository?
• What lessons have you learned?
• What would you have done differently?

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Developing a Tissue Repository
Presented by William E. Grizzle, MD,
PhD Katherine C. Sexton, MBA THE UNIVERSITY OF
ALABAMA AT BIRMINGHAM Tissue Collection and
Banking Facility Forward requests for
information to sexton_at_path.uab or call
205-934-6071