Tissue Biorepositories: Do You Really Want
to Know How the Sausage is Made?
David A. August
Professor of Surgery
The Cancer Institute of New Jersey
UMDNJ / Robert Wood Johnson Medical School
The Cancer
Institute of
New Jersey
CINJ “SNP” Protocol
Goal: to identify genetic variants as
markers for
• risk of developing breast cancer
• earlier age of diagnosis
• outcomes
1168 patients consented
980 genomic DNAs isolated
Demographics to date from chart
review
Collaborative studies with:
•
•
•
•
•
Dr. Arnold J. Levine
Dr. Vassiliki Karantza-Wadsworth
Dr. Shridar Ganesan
Dr. Bruce Haffty
Dr. Mark Brenneman
Race
African American
Asian
Caucasian
Hispanic
Indian
Other
Number of Patients
38
32
613
37
19
22
%
5.0
4.2
80.6
4.9
2.5
2.9
Tumor Type
Colloid/Mucinous
DCIS
Invasive Ductal
Invasive Lobular
LCIS/Atypical hyperplasia
Medullary
Metaplastic
Other
Number of Patients
11
63
561
82
5
4
4
19
%
1.5
8.4
74.9
11.0
0.7
0.5
0.5
2.5
ER Status
Positive
Negative
Number of Patients
531
180
%
74.7
25.3
PR Status
Positive
Negative
Number of Patients
445
252
%
63.9
36.2
Her2/Neu Status
Not amplified or 0-2+ IHC
Amplified or 3+ IHC
Number of Patients
420
100
%
80.8
19.2
Stage
Control/LCIS /Atypical
hyperplasia
0
1
IIA
IIB
IIIA
IIIB
IIIC
IV
Number of Patients
%
5
62
260
161
105
44
25
10
28
0.7
8.9
37.1
23
15
6.3
3.6
1.4
4
Tumor
T0
T1
T2
T3
T4
%
5.2
46.3
24.7
6.5
4.6
Node status
N0
N1
N2
N3
%
47.6
32.5
3.7
0.2
Metastatic Status
M0
M1
%
83.4
3.5
Recurrence Status
Yes
No
%
15.5
84.5
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
NCI_Best_Practices_060507biospecimens.cancer.gov
Types of Tissue Support
Clinical
Basic
• Tissue banking (deidentified:discarded, annotated)
• Protocol specific support
• Translational research
• Bench support
Front End / Back End
Clinical Processes (collectors)
•Protocol development
•Regulatory approval
•Subject consent
•Tissue acquisition
•Clinical analyses
•Initial processing
•Clinical annotation
•Linkage/de-identification
•Tissue storage
•Acquisition QA
•Longitudinal annotation
Technical Processes
(repository, recipients)
•Tissue storage
•Quality assurance
•Sample preparation
•Sample distribution
•Database management
•End user support
Clinical Uses
• Prognosis
• Risk assessment
• Pharmacodynamics (Phase O trials)
• “Fingerprinting”
• Inheritance analysis
• Etiology
• Response assessment
• Response prediction
The Worker Bees
• Director
• Pathologist
• Database development/management/support
• Manager
• Technicians (histo, retrieval, IHC, TMA)
• Data managers, research nurses, chart abstracters
• Regulatory manager
• Protocol support (writer, “shepherd”, consultant)
• Consent docents