UCRF Re- evalua,on. UNC Health Registry/Cancer Survivorship Cohort. April 16, 2014
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1 UCRF Re- evalua,on UNC Health Registry/Cancer Survivorship Cohort April 16, 2014
2 Goals Create a cancer survivorship cohort of 10,000 pa,ents diagnosed and/or treated at UNC that focuses on cancers demonstra,ng health disparity and that serves as a valuable research resource to inves,gators Unique resource among 8 na,onwide that include all cancers UNC addi,onally unique Public ins,tu,on Includes minori,es and under- served popula,on Clinically annotated processed biospecimens Provides a voice to NC cancer pa,ents regarding the future of healthcare and cancer treatment Integrated with UNCseq consen,ng, biospecimen collec,on & clinical annota,on Using HR/CSC as a use case, support and create flexible LCCC core infrastructure using informa,cs to collect, track, integrate, distribute, and analyze data sources for cancer research, for example UNCseq
3 4664 Enrolled 76% with Blood 2292 with Ques,onnaire 564 with Tissue 2493 with Medical Records Progress - Cohort
4 Informa,cs Tools Customized & Developed for Pa,ent- Centered LCCC Research Efforts Central Pa,ent Registry (CPR) Video Consent (EDC) Mi- Co electronic signature consent/ HIPAA (CSCC) CDART (TCRDMS) Computer Assisted Telephone Interview (CSCC) Electronic Registry System (ERS) Pa,ent Tracking System (PATSY) (Sheps Center) Lineberger Data Warehouse and Biospecimen Repository (LDBR) Secure Medical Work Space (NC TraCS) Data Sharing Tracking System (ICISS)
5 IMPACT: THE LCCC RESEARCH INFRASTRUCTURE SAS- UNC Partnership - DEVELOP HOA TOOL - LINK ALL HR/CSC DATA SOURCES LCCC Sta,s,cal Analysis - ANALYTIC TEAM * RESPOND TO COHORT DISCOVERY * CREATE ANALYTIC DATA SETS Clinical Studies & Registries - MONITORS DATA QUALITY ID PATIENTS, RECRUITMENT, BIOSPECIMEN COLLECTION, UNC Hospital INTERVIEW, MRA, AND Tumor Registry LCCC Bioinforma,cs FOLLOW- UP: - UNCSEQ - READY ACCESS - ONCORE TO ABSTRACTED MR DATA - QC MRA - DATA BREAST CANCER REGISTRY TPF - MELANOMA REGISTRY BSP - GU CANCER REGISTRY - LINKS CONSENTS - CAROLINA TO OPERATING SENIORS ROOM SCHEDULE - SUPPORT CLINICAL ANNOTATION OF TUMOR LIMS SPECIMENS REPORTING * STANDARDIZED * CENTRALIZED Cancer Survivorship Cohort LDBR CDW/EMR EPIC - CUSTOMIZED SOFTWARE TOOLS - IMPLEMENT MEDICAL RECORDS - FACILITATES DATA LINKAGES DATA TRANSFER - DATA ARCHITECTURE USING - SECURE MEDICAL WORKSPACE COMMON DATA PLATFORM - SECURITY Central Pa,ent Registry Link Data Sharing Tracking System - QUICK EASY ACCESS TO DATA - REPORTS ON MANUSCRIPT/GRANTS PROGRESS Complex Data Capture System - PAPERLESS DATA COLLECTION WITH REALTIME QC - ELECTRONIC GLOBAL CONSENT/HIPAA Pa,ent Tracking System CUSTOMIZABLE PATIENT- LEVEL STUDY EVENT TRACKING - UNIQUE RESEARCH ID ASSIGNMENT LINKED TO MRN - LINKS TO GLOBAL CONSENT AND HIPAA
6 Data Sharing Tracking requests since 2012 Data sharing website access established - June 2013 Volume of report and data requests increasing An,cipate >100 requests in 2014 Na,onal exposure of research data (abstracts, posters & manuscripts) Report and data request usage by year Year * Represents only 3 months of 2014 Number * 24 Photo Citation:
7 Impact Publica,ons & Grants Top three examples Manuscript Proposals/Papers Preoperative quality of life and surgical outcomes in gynecologic oncology patients: A new predictor of operative risk? Gynecologic Oncology Ms. No.: GYN accepted 3/15/2014 Risk factors for fecal incontinence amongst patients undergoing cancer treatment. AUGS 35th Annual Scientific Meeting The association between the geriatric assessment and health related quality of life for older adults with cancer. In progress. Ancillary Study Proposals /Grants** Feasibility of using smart scales for weight gain prevention in African American breast cancer survivors: a randomized pilot study. High-throughput DNA-methylation profiling from fixed melanocytic tissues and shed DNA. Multicenter, prospective analysis of patterns of the failure among patients with breast cancer brain metastases treated with stereotactic radiosurgery, whole brain radiation therapy or both. Total attributable to UCRF* 8 Publication proposals/manuscripts 12 Ancillary study proposals/grants Supported research projects/grants totaling 1.3 million dollars - through recruitment, biospecimen, questionnaire, and medical records data collection. * * No grants have been secured to broadly support HR/CSC development & infrastructure.
8 Impact of UCRF Investment to Date Impact of UCRF Investment* to Date Developed clinical research with junior faculty, fellows and graduate students: Crane, Doll, Pergolotti Recruitments Key UNC collaborators UCRF recruited faculty members attracted by cohort infrastructure: Mendez, Nielsen, Reeves, Rosenstein, Muss, Basch, Lund, Nichols Represents specialty areas including: Nutrition, Epidemiology, Gynecologic Oncology, Occupational Sciences/Therapy, Health Policy and Management, Urologic Oncology, Psychiatry, Gerontology v Schools of Medicine, Public Health, Nursing v LCCC Cores (Bioinformatics, Laboratory, Biostatistics) v Patient Resources: UNCseq, Registries (Breast, Melanoma, Urology), ICISS v UNC Centers: NCTraCS (CTSA), Sheps Center, CSCC, Key external collaborators v MD Anderson Cancer Center v Education Development Center, EDC (Boston, MA) v Electronic Registry System, Inc., ERS (Cincinnati, Ohio) v Statistical Analysis Systems, SAS (Cary, NC) - Since 2008, UCRF has invested $989,390 in cancer research infrastructure and $3,048,693 on development and implementation of the valuable Cancer Survivorship Cohort - The total combined budget (infrastructure + Cohort) for FY2014 is $800,000
9 Challenges Ongoing needs for IT and analy,c support Improved turn- around for requests Comprehensive understanding of clinical data model Communica,on to LCCC members Completeness of data Biospecimens Abstracted medical records Baseline interview Follow- up interviews Photo Citation:
10 Short Term (1-2 years) Infrastructure Establish follow- up of cohort Future Plans Establish and retain IT/biosta,s,cians for SAS HOA/clinical data maintenance, customiza,on and analysis Establish data linkage with NC vital stats, ICISS claims data, geocode cohort Establish teams of super- users Research UNC- wide public rela,ons campaign to aoract users Facilitate iden,fica,on of pa,ent sets for clinical trials Photo Citation: (# ) (
11 Long Term (3-5 years) Infrastructure Future Plans Complete recruitment of 10,000 cancer survivors Progress to long- term follow- up of cohort Research Con,nue to recruit users, publish and submit grants Develop sta,s,cal methods for large integrated data mining (e.g., genomics, clinical care, pa,ent- reported outcomes) Photo Citations:
12 Acknowledgements HR/CSC Advisory Committee IT Team: LCCC, CDW-H, CSCC LCCC Lab Cores: TPF, BSP Hospital Tumor Registry Patient Task Force Clinical Care Teams LDBR Data Sharing Committee SAS and other Corporate Partners
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