1. Kathryn E. Weaver, PhD, MPH co-Principal Investigator, WF NCORP RB Presentation to Translational Cancer Genomics Working Group December 16 th, 2014

2.  What is NCORP and the Wake Forest NCORP Research Base?  How can the Research Base help you do your research?  What are potential opportunities for genomics research within the Wake Forest NCORP Research Base?

4. 4 What is NCORP? A community-based research program Builds upon the scope and activities of NCI’s previously supported community networks NCI Community Clinical Oncology Program & NCI Community Cancer Centers Program Receives support through UG1 grant awards Funding of $93 million annually for 5 years

5. 5 NCORP Structure NCORP consists of 3 components: Research Bases Community Sites Minority/Underserved Community Sites

6. Alliance NCORP Research Base Jan Buckner, MD Rochester, MN Children's Oncology Group (COG) NCORP Research Base Brad Pollock, MPH, PhD Philadelphia, PA ECOG-ACRIN NCORP Research Base Lynne Wagner, PhD Philadelphia, PA NRG Oncology NCORP Research Base Deborah Watkins Bruner, PhD, RN Philadelphia, PA SWOG NCORP Research Base Charles Blanke, MD Portland, OR University of Rochester NCORP Research Base Gary Morrow, PhD, MS Rochester, NY Wake Forest NCORP Research Base Glenn Lesser, MD Winston-Salem, NC

7.  Funded as of 8/1/14 through 7/31/19  Approximately $18 million total costs over 5 years Funds infrastructure to design, develop, conduct and report community-based cancer control and CCDR clinical trials (i.e. not treatment trials) Correlative aspects of trials: imaging, PRO’s, biospecimen collection and analysis

8. Counseling/Geriatrics  Ed Shaw, MD, MA Public Health Sciences  Doug Case, PhD  Mara Vitolins, DrPH, MPH, RD  Suzanne Danhauer, PhD Cancer Center  Carla Strom, MLA Psychiatry/Beh. Sciences  Steve Rapp, PhD NCORP Community  Vivien Sheidler, RN  Glenn Lesser, MD: PI  Kathryn Weaver, PhD, MPH: co-PI  Executive Steering Committee

9. 9 NCORP Sites

10.  National network of oncology practices that can be used to recruit patients for approved NCORP studies  Recruitment/data collection infrastructure funded at each site; NCI pays per case reimbursement  Regulatory, data management, nursing, and some laboratory support covered by core grant

12. 1. Develop primary concepts focused on genomics Breast biomarkers study 2. Develop ancillary study to symptom management or CCDR studies in development Epigenetic pilot within anxiety-reduction intervention study (Danhauer & Howard)

13.  Develop genomic and/or biomarker models to predict radiation-induced skin toxicity in women receiving breast/axillary/chest wall radiation for breast cancer Genome-wide SNP analysis Markers of oxidative DNA damage Double strand DNA damage  1000 patients, 60% minority, accrued from 11/11 – 5/13

14.  Cardiovascular Injury  Neurotoxicity- radiation and chemotherapy  Symptoms and toxicities across the survivorship spectrum Anxiety Skin toxicity Arthralgia/myalgia- aromatase-inhibitors Taste and smell Smoking cessation

15. 15 Cancer Care Delivery Research (CCDR) Examines how social factors, financing systems, organizational structures/processes, health technologies, and healthcare provider and individual behaviors affect: Cancer outcomes Access to and quality of care Cancer care costs Health and well-being of cancer patients and survivors NCORP’s CCDR focus encompasses individuals, families, organizations, institutions, providers, communities, populations, and their interactions.

16.  Practice and provider factors that influence quality of care  Post-treatment surveillance- patterns and personalization  Interventions to reduce disparities

17.  Genomic Medicine/Targeted Therapeutics Identify and characterize potential opportunities to increase patient benefit and/or decrease patient harm Examine magnitude of and reasons for appropriate/inappropriate use in the community setting Evaluate impact on cost and value of appropriate/inappropriate use in community setting Identify, characterize, develop and test patient, provider or system interventions that advance effective and appropriate use of genomic information, including appropriate communication of the “omics” information Characterize the extent of use, interpretation, and utility of free-market genomic panels