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The UWCCC/WON Molecular Tumor Board (MTB)
& Registration ProtocolMark E. Burkard MD PhD
WON fall meetingOctober 24, 2015
“I shall never be content until the beneficent influence of the University reaches every home of the state.”
-Charles Van Hise 1904
Launched September 2015UWCCC/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)
MTB Chairs & CollaboratorsUWCCCMark Burkard, Dusty Deming & Josh Lang
Research
Jill Kolesar & Anne Traynor
Laboratory Science
Bill Rehrauer & Jennifer Laffin
Pathology
Kristina Matkowskyj & Darya Buehler
WONGundersen Lutheran/LacrosseDr. Ben M. Parsons
St. Vincent/GB OncologyDr. Ruth Warren
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
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.
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
The WON MTB Workflow
William RehrauerDeaprtment of Pathology
Request UW Pathology review/genomic sequencing
UW Collaborative Genomics CoreUWHC clinical labs
The WON MTB Workflow
The UWCCC Molecular Tumor Board
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 priorRecommendation returned to treating physician
Cost: $0 … but enroll patient in registry
Cases are de-identified for presentation
The UWCCC MTB Registration Protocol
The MTB Registration Protocol
• To determine the frequency of acceptance of MTB clinical recommendations
• To evaluate effectiveness of precision targeted therapies
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
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
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
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
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
Timelines
• MTB services are now available
• MTB Registration Protocol available early 2016
How to access MTB and testing
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
The OutReach Online Portal• Hosted by the Wisconsin State Lab of Hygiene
• Used to:Submit Requisition for Genomic TestingRequest MTB ConsultationView and print
UWCGC Test ReportsMTB Recommendations
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
The OutReach Online Portal
Click on “Orders”(bottom right)
The OutReach Online Portal
Click on “New Order” (lower left)
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
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”
