NCI Center for Cancer Research

1
NCI Center for Cancer Research

• Created in Jan. 2001
• Approx. 3000 staff
• 300 PIs
• 200 Open Protocols
• 1,200 patients on Treatment Protocols annually
• 40,000 total patients annually (Screened,
  Outpatient, non-Treatment Protocol)

2
CCR Biospecimen Facility
MTP
Other CCR Researchers
IT/ Tracking
CCR Tissue Biospecimen Facility
Storage
MOCRU
Frederick
Pathology
Surgery Procedures
3
CCR Biospecimen Facility
Facility available to all CCR Investigators
conducting clinical trials to ensure tissue and
blood samples acquired from patients are handled
in accordance with Federal regulations and are
efficiently prepared for subsequent analysis.
4
CCR Biospecimen Facility Two Components
MTP
IT/ Tracking
MOCRU
CCR Blood Processing Facility
CCR Tissue Procurement and Processing Facility
Storage
Frederick
Pathology
Surgery Procedures
5
Surgery and Procedures
Interaction and coordination with surgery,
interventional radiology, and the clinics that
are isolating solid tissue is very important to
the success of the facility.
Operating room schedules are posted Friday
afternoon for the following week. Procedures
and/or process will need to be put in place for
the collection of materials from interventional
radiology and the clinics. Tissue procurement
form is required for all tissue collection
(currently only in hard copy) and must be
submitted with specimen to pathology. Once
tissue is procured, the next step is pathological
evaluation.
6
Pathology
A critical partner in the Tissue Procurement and
Processing Facility. It is imperative that a
pathologist work in collaboration with this
facility to ensure proper sectioning of the
obtained sample for histopathologic examination
and diagnosis. It is the pathologist who
determines what sample goes to the PI for
research purposes.
Pathologist (hot-seat resident) meets tissue
procurement nurse in the Tissue Procurement and
Processing Facility for evaluation of solid
tissue specimen. Tissue procurement form is
required for all tissue collection (currently
only in hard copy) and must be submitted with
specimen to pathology. Pathologist makes
determination of what is kept for pathology and
what can be released for Clinical Research. Data
management system to record and track tissue
procurement, processing, distribution,
storage. This system/approach needs to be
compatible with and interface with existing
system being used by the Laboratory of Pathology,
SoftPath LIS.
7
IT/Tracking
A critical element for the Tissue Procurement and
Processing Facility will be the Information
Technology and Tracking component.
Needs/Vision Sample tracking from point of
isolation from the patient, to evaluation by
pathologist, to processing, to distribution of
research portion to protocol PI. This module
would be compatible with other components that
manage patient information (C3D), results from
assays performed on isolated tissue, and
repository/storage database(s). Tissue sample
identification and tracking (barcoding for
example) integrated into database management.
8
MOCRU
MOCRU is the clinical partner to all CCR
principal investigators. The physicians in MOCRU
do not always have a laboratory for the
processing of tissues. The procurement and
processing facility will be useful for those PIs
who need to have tissues stabilized and processed
before distribution for endpoint assays and
studies.
MOCRU has the following cores - PK/PD with Doug
Figg - Blood processing (associated with pk/pd
above) - Doug Figg - (note this is considered a
component of the overall CCR Tissue Procurement
and Processing Facility) - Molecular Targets
core - SAIC hire in process - preclinical models
core - Jane Trepel
9
Molecular Therapeutics Program
Objectives 1. conduct multi-disciplinary
interrogation of molecular pathways 2. provide
needed infrastructure and support to preclinical
drug development 3. participate in the design and
coordination of clinical trials. Preclinical
Pharmacokinetics (Doug Figg) This core will
develop analytical methods to quantitate new
anticancer agents and to understand the
disposition of the investigation agent.
Chemistry, Structural Optimization and
Formulation (Dick Cysyk) Provide critical input
in the areas of chemistry, structural
optimization and formulation. Toxicology (Dick
Cysyk) In collaboration with FDA scientists,
this component will conduct toxicological studies
of drugs in development, with particular emphasis
on hepatotoxicity. Preclinical Animal Model
Strategy Team (Lyuba Varticovski) Works to
develop animal models for drug testing that mimic
the progression of human disease and may be
better predictors of clinical success and
mechanisms of drug resistance. Molecular
Oncology (Maria Zajac-Kaye/Pat Steeg) This
effort will assist PIs in molecular and cellular
biology experiments in cell lines, animal tissues
and human tumor biopsies to evaluate mechanisms
of action, optimal combinations and answer other
critical questions.
10
Frederick
Several activities in Frederick need to be kept
in mind McKesson BioServices operates the
Wedgewood biorepository - site for short-term and
long-term storage of tissue samples Rick
Bedigian/Lionel Feigenbaum - SAIC development of
a validated metastasis cell repository for access
by CCR PIs - vision is to expand this to include
additional cell lines, and activities around mice
which would include collection, storage and
tracking of tissue SAIC - processing facility at
Frederick - already established currier service
from CC to Frederick

11
Storage
Objective Store tissue samples at various stages
of processing with intenetion of developing
virtual system for determining who has what
samples and for facilitating collaborations among
investigators interested in similar
questions Options Storage by individual
PIs Storage in common repository -
Short-term - Long-term
12
CCR Tissue Procurement and Processing Facility
13
CCR Tissue Procurement and Processing Facility

• Mission
• To provide a resource to the CCR community that
  will facilitate the procurement of research
  samples and enable the processing of solid tissue
  samples in accordance with federal regulations.
• Serving the needs of all CCR PIs running
  clinical research trials to ensure having high
  quality, properly diagnosed samples to use for
  research studies.

14
CCR Tissue Procurement and Processing Facility

• Not an attempt to disrupt ongoing tissue
  procurement and processing activities that are
  working.

15
CCR Tissue Procurement and Processing Facility

• Objectives
• Provide efficient coordination among procurement,
  pathology, and processing steps for clinical
  research samples
• Procure tissue samples from patients on clinical
  trials ensuring required sample is obtained for
  pathology review
• Pathologist is on hand to identify the section
  required for Pathology
• Tissue procurement form accompanies sample
• Prepare and/or process biospecimen, as needed per
  approved IRB protocol
• Knowledge of clinical trials and tissue
  preparation needs
• Interact with protocol PIs to ensure needs
  surrounding procurement and processing of
  research samples are met

16
CCR Tissue Procurement and Processing Facility

• Proposed Location
• Occupy Laboratory of Pathology space currently
  housing the frozen section room and adjacent to
  surgical suite hallway
• Proposed Staffing
• Tissue procurement nurse
• Tissue processing specialist
• Pathology resident as needed for sample sectioning

17
CCR Tissue Procurement and Processing Facility

• Required Equipment
• Biologic safety cabinet
• Liquid nitrogen source tank and storage tank
• Freezers -20 and -80
• Refrigerator
• Dry and wet ice
• Centrifuges
• Computer/printer
• General pathology/processing reagents
• General laboratory supplies

18
CCR Tissue Procurement and Processing Facility

• Process Tissue from the OR
• Advanced scheduling of OR procedures enables
  scheduling for pathologist to assist on those
  days/times
• Tissue procurement nurse obtains tissue from
  surgeon
• Pathologist determines what section must be taken
  to pathology and what can be used for research
• Tissue processing specialist prepares research
  tissue per request of the PI
• To include, but not limited to placing in
  solution, snap freezing, holding on ice,
• PI is notified that sample is ready for pick-up
• Clinical Center courier may be used for delivery
  in some cases

19
CCR Tissue Procurement and Processing Facility

• Process Tissue from the clinic
• Sample delivered to Tissue Procurement and
  Processing Facility
• Pathologist meets sample at this location and
  determines what section must be taken to
  pathology and what can be used for research
• Tissue processing specialist prepares research
  tissue per request of the PI
• To include, but not limited to placing in
  solution, snap freezing, holding on ice,
• PI is notified that sample is ready for pick-up
• Clinical Center courier may be used for delivery
  in some cases

20
CCR Tissue Procurement and Processing Facility

• Processing for subsequent assays
• PI responsibility
• As we move forward there may be some potential
  for some basic processing to be done in facility
  (solid tissue vs. blood)
• PI will be contacted that tissue is ready to be
  collected
• Store personally
• Storage in Frederick Repository
• Long term vs short term
• Database
• Tracking procurement and processing
• Availability of samples across CCR to stimulate
  collaboration
• Needs to be developed - will be caBIG compliant -
  will work with NCICB

21
CCR Blood Processing Facility
22
CCR Blood Processing Facility Mission

• To provide a resource to the CCR community that
  will facilitate the handling and processing of
  research blood samples in accordance with Federal
  regulations.
• To ensure that PIs conducting clinical research
  receive high quality, properly prepared and
  stored samples from patient blood or other body
  fluid collections.

23
CCR Blood Processing Facility

• Objectives
• Provide efficient coordination of procurement and
  processing of clinical research samples
• Provide one location where blood and other body
  fluid samples can be received, triaged and
  processed
• Prepare and/or process blood, per approved IRB
  protocol
• Knowledge of clinical trials and sample
  preparation for PK/PD, endpoint assays, etc
• Development of and an adherence to sample
  handling, processing and storage SOPs
• Interact with protocol PIs to ensure blood
  processing needs are met

24
CCR Blood Processing Facility

• Proposed Space Needs
• One centrally-located module, potentially,
  convenient to Clinics and in close proximity to
  CCR Tissue Procurement and Processing Facility
• Establish a facility that could be CLIA-certified
• Proposed Staffing
• Presently, one supervisor and two research
  technicians
• Required Equipment
• Evaluate present blood processing equipment and
  enhance to provide two fully-equipped,
  self-contained stations for handling,
  processing and shipping of patient samples,
  including biological safety cabinets,
  centrifuges, control rate freezing chambers,
  freezers,

25
CCR Blood Processing Facility

• Process Blood or other samples from Clinics
• - Delivered to Processing Lab or Picked-up from
  Clinics/Hospital
• - Samples correlated to and linked by bar-code
  to IRB Protocol Protocol requirements dictate
  subsequent steps
• Processed or frozen on site
• Triaged to PI laboratory, NCI-Frederick
  Clinical Services Laboratory or Repository by
  courier services
• Short-term/active storage in on-site freezers
• Long-term/archival storage in NCI-Frederick
  repositories
• - Linkage between sample bar code and storage
  facility databases to permit efficient sample
  retrieval

26
Other needs

• Standards defined, Processes established,SOPs
  created
• Database/Information Technology
• Create a Data Sharing Plan
• Integration with SoftPath LIS and the CC CRIS
• Tracking and storage
• Determine Support Model
• Keep driving the point - half of the worth of the
  research is lost if you dont invest in the
  proper data handling

27
(No Transcript)