The document summarizes the UWCCC/WON Molecular Tumor Board (MTB) and Registration Protocol. The MTB is a panel of experts that provides treatment recommendations based on pathology or genomics analysis. Physicians can submit cases for review to receive recommendations for clinical trials, off-label drugs, or standard treatment. The Registration Protocol collects genomic, clinical, and outcome data to evaluate the effectiveness of targeted therapies recommended by the MTB.

1. The UWCCC/WON Molecular
Tumor Board (MTB)
& Registration Protocol
Mark E. Burkard MD PhD
WON fall meeting
October 24, 2015

2. “I shall never be content until the
beneficent influence of the
University reaches every home of
the state.”
-Charles Van Hise 1904

3. Launched September 2015
UWCCC/WON Molecular Tumor Board
Genetics experts oncologists, pathologists, pharmacologists, pharmacists, cancer researchers
Submit pathology or genomics analysis
Recommendations
• Clinical trial
• Off-label treatment
• Standard treatment
(not targeted)

4. MTB Chairs & Collaborators
UWCCC
Mark Burkard, Dusty Deming &
Josh Lang
Research
Jill Kolesar & Anne Traynor
Laboratory Science
Bill Rehrauer & Jennifer Laffin
Pathology
Kristina Matkowskyj & Darya
Buehler
WON
Gundersen Lutheran/Lacrosse
Dr. Ben M. Parsons
St. Vincent/GB Oncology
Dr. Ruth Warren

5. What to submit
Clinical case information:
• Summary (age, diagnosis, stage, clinical status)
• Prior treatments for metastatic cancer
• Measurable disease (Y/N)
• Sample being tested
• Other clinically relevant information (clinical trial eligibility)
• Specific question
Specimen and/or molecular data:
• Specimen for genomic testing
• Genomic test report

6. What you get
Recommendation:
– Clinical trials
– Off label use of targeted drugs*
– No recommendation
*Recommendations will adhere to an dynamic guidance document that
specifies when off-label therapies can be recommended.

7. MTB vs. Registration Protocol
• MTB:
– Expert advice on precision medicine
– Commitment to research and using the best
clinical evidence
• Registration Protocol:
– Research resource with genomic, clinical and outcome
data
– Available to WON members

8. The WON MTB Workflow

9. William Rehrauer
Deaprtment of Pathology
Request UW Pathology
review/genomic sequencing
UW Collaborative Genomics Core
UWHC clinical labs

10. The WON MTB Workflow

11. The UWCCC Molecular
Tumor Board

12. MTB Meetings
When: 1st and 3rd Thursday of each month 4:30pm
Where: UWCCC or Web-based Conference
Who: Molecular tumor board chairs, trainees, WON
collaborators, presenting physicians (optional)
What: Present up to 4 cases, submitted 10 d prior
Recommendation returned to treating physician
Cost: $0 … but enroll patient in registry
Cases are de-identified for presentation

13. The UWCCC MTB
Registration Protocol

14. The MTB Registration Protocol
• To determine the frequency of acceptance of MTB clinical
recommendations
• To evaluate effectiveness of precision targeted therapies

15. The MTB Registration Protocol
• Open to all pts > 18 yo with histologically confirmed
solid or hematological malignancy who will have
genetic testing
• Signed consent form
• All molecular tumor profiling laboratory reports
allowed

16. Recruitment to the MTB
Registration Protocol
• Presented and consented to subjects during regularly
scheduled clinic appointments
• Subjects are registered into the UWCCC OnCore
Database
• Baseline and follow up clinical, genetic and
demographic information collected and stored in
OnCore

17. Recruitment to the MTB &
Registration Protocol
Baseline Visit MTB
Meeting
(Days 14-28)
Follow-up Visits while on
molecularly-targeted
therapy
(if any)b
Annually
Informed Consent X
Collect required data
elements X X
Obtain tumor tissue for
genomic testing X Xc
Order genomic testa X Xc
Order MTB X
Obtain DNA blood sample for
Lang Lab, path slides for
Kolesar Lab, and tissue for
Deming Lab (if applicable)d
X
Query Wisconsin Cancer
Registry X

18. Archived Tumor for the MTB
Registration Protocol
• Formalin-fixed paraffin block (preferred)
OR
• Five- 5 micron sections placed on positively charged
slides
 Slides should be labeled in a solvent-resistant manner with
subject ID and slide numbers
 Allow slides 1 and 3 to air dry for ~24 hrs prior to shipping
 Slide 2 should be H&E stained and cover slipped prior to
shipping
 Slides 4 and 5 should be unstained

19. Blood Samples for the MTB
Registration Protocol
Prior to beginning targeted therapy:
• 2-10 mL Cellsave tubes
• 2-10mL EDTA tubes Formalin-fixed paraffin block
(preferred)
Samples will be processed for plasma and
nucleated cells for analysis of cancer relevant
targets and may be used to correlate with
mutations observed in tumor tissue

20. Timelines
• MTB services are now available
• MTB Registration Protocol available early 2016

21. How to access MTB and testing

22. UW Collaborative Genomics Core
www.med.wisc.edu/uwcgc
• Online Portal Access
• Portal Authorization Form
• Tests by Method
• Tests by Type
• Clinical Resources
• Genomic Research Resources

23. The OutReach Online Portal
• Hosted by the Wisconsin State Lab of Hygiene
• Used to:
Submit Requisition for Genomic Testing
Request MTB Consultation
View and print
UWCGC Test Reports
MTB Recommendations

24. The OutReach Online Portal
• The OutReach website address is
https://www.slh.wisc.edu/elabs/Cytogenetics/
• OutReach can only be accessed by entering a
valid user ID and password

25. The OutReach Online Portal
Click on
“Orders”
(bottom right)

26. The OutReach Online Portal
Click on “New
Order” (lower
left)

27. The OutReach Online Portal
Submitting MD
is selected by
clicking “Set
Submitter”
(alphabetical
list of MDs is
displayed)
Prior pts and
new pts can be
accessed here

28. The OutReach Online Portal
Select “Order
Type” (MTB)
and select test
to be ordered
from the pull
down MTB
Prior pts and
new pts can be
accessed here
Click “Place
Order”

29. MTB Contact Information
Marissa Schuh, Coordinator
mrschuh@uwcarbone.wisc.edu
Dona Alberti, Administrator
dba@uwcarbone.wisc.edu