1. TIES F2F 2016 Augusta University
November 4, 2016

2. Who is AU? MCG (1833–2011) GHSU (2011–2013)
2013: Georgia Regents University = GHSU + ASU

3. Now AU

4. Founded in 1828
13th -oldest medical school
8th -largest medical school
Nine Colleges
9000 students (across campuses 240 medical students/year)
Supporting GR Health System
478-bed AU Health Medical Center
154-bed Children's Hospital of Georgia

5. Georgia Cancer Center
The Georgia Cancer Center has three expressions, one laboratory-based, one clinic-based and one education-based.
Our research facilities celebrate innovation, combining form with function to offer our scientists an environment for collaboration and discovery.

6. GCC Areas of Research Focus
Cancer Immunology, Inflammation and Tolerance
Cancer Prevention & Control
Molecular Oncology & Biomarkers
Tumor Signaling & Angiogenesis

7. Our Team Our Team Repository Side:
Sameera Qureshi – Biorepository Lab Associate
Rahil Khan – Biorepository Lab Assistant
Lelyand Stone – Biorepository Lab Assistant
Denise Harper – Biorepository Study Coordinator
Roni Bollag –Biorepository Director
Nita Maihle – Associate Director, TIES Liaison
Our Team

8. Our Team (con’t) IT Side:
Mia Jolly – Business Analyst/Project Coordinator
Pankhil Patel – DBA
Colleen Cain – Director Enterprise Application Systems
Charles Busbee – Manager, Database & Application  Administration
Michael Casdorph – Associate VP Academic & Research Technology

9. The AU Biorepository: Tumor Bank:
Provides MCG researchers access to high quality, annotated specimens, to support basic and clinical cancer research
Shared resource for the Cancer Center, important for its NCI designation process (P30 grant)
BRAG-Onc:
Serves as coordinating hub and central repository for the statewide repository network

10. TCRN Challenges
EHR = Cerner Millenium / Pathnet (switched from Copath in 2005)
Biorepository Database: TissueMetrix
Mostly non-functional for translational research applications
Soon to convert to LabVantage
Clinical Trials Database: Oncore

11. AU Pathology 12 - 14,000 surgical specimens/year
Since 2000 (target for retrospective data capture) – 255,000 reports
MCG surgical emphases: endocrine oncology, urologic oncology, gynecological oncology

12. Safe Harbor at GRU
DeID software package licensed (Y3) from DeIData systems implemented to generate over 200,000 reports with scrubbed identifiers
QI plan completed; current documentation in RedCap

13. Compliance at AU
obtained IRB sanction of TIES consortium aggregate data to be designated as non- human subjects research
IRB renewal for TIES project has been ongoing
Working with IRB to include TIES in model to procure surgical pathology cases

14. IRB Continuing Review

15. Governance at GRU
Creation of GRU TIES project approval committee to evaluate external and internal TIES project submissions, in conformance with TCRN governance mandate.
Natasha Savage
Nita Maihle
Roni Bollag

16. [This slide intentionally left blank]

17. Total Reports to-date 209,676 reports Report Types Autopsy Surgical
Bone marrow
Cytology (likely superfluous)

18. IT support at AU
Export of retrospective surgical pathology reports from Cerner Pathnet into firewall-protected honest brokerage archive via HL7 pipeline
Feed-forward pipeline for download of current surgical pathology reports
Some problems due to interim reports double-reported
Solved seamlessly by Girish Chavan

19. Dissemination

20. Current Users at AU Only 10 with active accounts
Need to recruit more devotees to TIES
Face-to-face discussions sometimes lead to ambiguity
Need to proselytize with regards to TIES :
Developing IRB protocol to include TIES documentation to support sample release
Cancer Center is migrating more to a self-directed case identification model
Integration of TIES with biorepository archive would make major improvement in biorepository service model

21. Efforts to Date Pathology Faculty Meetings
Core Facility Poster Session
GCC Website Advert
PRIDE symposium demo, 2015 & 2016
IRB Protocol in Development for FFPE Accession: “An Honest Broker Protocol for Provision of FFPE materials for Research Using TIES Deidentified Informatics”
Face to Face with Colleagues

22. Roni J. Bollag, MD, PhD Suash Sharma, MD
Pilot Project: Demographic Characterization of Tenosynovial Giant Cell Tumor
Roni J. Bollag, MD, PhD
Suash Sharma, MD

23. PVNS/GCT Pigmented Villonodular Synovitis (PVNS)
Tenosynovial Giant Cell Tumor (TGCT) = Giant Cell Tumor of Tendon Sheath
Incidence ~ 600 new cases per year in US, often young adults
Clonal neoplastic process resulting in over-expression of CSF1 in synovium
Frequently due to genetic translocation: t(1;2) CSF1:COL6A3
Propagation of neoplastic clone (autocrine)
Reactive inflammatory process with proliferation & recruitment of CSF1R-expressing cells: macrophages, giant cells, osteoclasts
Surgery is standard of care (e.g., joint replacement, amputation)
Pharmaceutical target: blockade of CSF-1 Receptor (orphan drug designation?)

24. TCRN output for GCT UPMC : 1190 patients UPENN: 396 patients
RPCI: 8 patients
AU: 73 patients
Total: 1667 patients

25. Graphic Output

26. Spreadsheet for PVNS / GCT

27. AU summary

28. Pilot Projects in Contemplation

29. Oligodendroglioma Prognosis
Cases with 1p / 19q deletion annotation
To be assessed for partial deletion status
Comparison between FISH and molecular annotation
[Dr. Suash Sharma]

30. Langerhans Cell Histiocytosis
Langerhans Cell Histiocytosis has been proven to be a clonal disorder among a large subset of cases showing BRAF V600E mutations
A subset of cases do not harbor this mutation (mostly MAP2K and ERK-activation pathways)

31. Langerhans Cell Histiocytosis
Identification of such mutations via NGS may further exemplify and characterize this disorder to demonstrate more universal clonality
Caveat for study: most cases have been acid- treated for decalcification – need to review for cases without decalcification

32. Toys to Integrate into TIES
Imaging systems
Bandwidth
LabVantage Software
TMA Construction
Nucleic Acid Isolation

33. Slide Scanning with Leica Ariol

34. Getting geared up to use the PE Vectra system

35. TMA Grand Master

36. Summary AU node is up and running: good things to come
Compliance is current from institutional perspective
Gaps in data upload – needs to be tweaked
Safe Harbor QA complete
Imaging, TMA, Computing upgrades
Pilot projects with inclusion of AU:
So far, so good…