The Wake Forest NCORP Research Base: Multisite Clinical Study Opportunities

Kathryn E. Weaver, PhD, MPHco-Principal Investigator, WF NCORP RBPresentation to Translational Cancer Genomics Working GroupDecember 16th, 2014

Outline

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?

What is NCORP and the Wake Forest NCORP Research Base?

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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

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NCORP Structure

NCORP consists of 3 components:

• Research Bases

• Community Sites

• Minority/Underserved Community Sites

NCORP Research Bases

Alliance NCORP Research BaseJan Buckner, MDRochester, MN

Children's Oncology Group (COG) NCORP Research Base

Brad Pollock, MPH, PhDPhiladelphia, PA

ECOG-ACRIN NCORP Research BaseLynne Wagner, PhDPhiladelphia, PA

NRG Oncology NCORP Research BaseDeborah Watkins Bruner, PhD, RNPhiladelphia, PA

SWOG NCORP Research BaseCharles Blanke, MDPortland, OR

University of Rochester NCORP Research BaseGary Morrow, PhD, MSRochester, NY

Wake Forest NCORP Research BaseGlenn Lesser, MDWinston-Salem, NC

Wake Forest NCORP Research Base

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

WF NCORP Leadership Team

Counseling/Geriatrics Ed Shaw, MD, MAPublic 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

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NCORP Sites

How can the Research Base help you with your research?

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

Opportunities for Genomics Research within WF NCORP Research Base

Ways to collaborate with the RB

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)

97609: Breast Biomarkers Study

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

Cancer Control Priorities

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

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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.

Examples of CCDR Priorities

Practice and provider factors that influence quality of care

Post-treatment surveillance- patterns and personalization

Interventions to reduce disparities

Potential NCI CCDR Priority Area

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