Christie Eheman, PhD, MSHP Cancer Surveillance Branch Division of Cancer Prevention and Control National Center for Chronic Disease Prevention and Health Promotion
1992 Cancer Registry Amendment Act, Public Law 102-515, authorized CDC to establish NPCR Provided funds to CDC for funding states and territories to enhance or plan/implement registries Work with states to develop model legislation and regulations Provide training on Central Registry operations Standardize a minimum set of data items Set national standards for completeness, timeliness and quality
48 funded programs 45 states, DC, Puerto Rico, Pacific Islands Jurisdiction NPCR U.S. population coverage - 96% percent In collaboration with NCI 100% population coverage NPCR Cancer Surveillance System Approximately 1.2 million new invasive cancer cases are submitted to CDC electronically each year Data base includes approximately 17.4 million invasive cancer cases from 1995 2007 CDC does not receive identifiers (name, address, SSN)
Membership organization central cancer registries in U.S. and Canada Supported by CDC, NCI, and other sponsoring organizations as well as membership fees, etc. Sets standards for data items and electronic data record structure Work group structure used to establish standards and include representatives from registries and other partners including CDC
Hospitals Outpatient centers Laboratories Radiation therapy centers Electronic Hard copy State Central Cancer Registry Cleaning Editing Analyzing Final data Medical oncology facilities Physicians
Record Identification Registry identification Patient ID number Demographic Race Age Sex State County Zip code Census tract Cancer Identification 1 Date of diagnosis Primary site Histology Reporting Source Stage/Progno stic Factors Summary stage Biomarkers (HER2, PR, ER) Followup/Death Date of last contact/death Vital status Cause of death Confidential Patient name Patient address 1 ICD-O codes conversion in data set to manage changes over time
Individual NPCR central cancer registries (CCRs) may collect more than is required for their own purposes including research Vital Status Collected from local vital statistics Linkage with National Death Index Encouraged and financially supported by CDC Not all registries have linked Not all registries that have linked have updated their data bases Significant manual review of partial matches
Less complete reporting from Physician offices Treatment facilities Out-patient clinics Entire data set (1995 - forward) is resubmitted each year and completeness improves over time Local funding for CCRs has been decreasing Furloughs Hiring freezes Data access for research
Data Met Criteria for Inclusion in United States Cancer Statistics State Diagnosis Years State Diagnosis Years AL 2000-2008 MT 1999-2008 AK 1999-2008 NE 1999-2008 AZ 1999-2008 NV 2000-2006, 2008 AR 2001, 2003-2008 NH 1999-2008 CA 1999-2008 NJ 1999-2008 CO 1999-2008 NY 1999-2008 DE 1999-2008 NC 2001-2008 DC 1999-2001, 2003-2007 ND 1999-2008 FL 1999-2008 OH 1999-2008 GA 1999-2008 OK 1999-2008 ID 1999-2008 OR 1999-2008 IL 1999-2008 PA 1999-2008 IN 1999-2008 RI 1999-2008 KS 1999-2008 SC 1999-2008 KY 1999-2008 SD 2001-2008 LA 1999-2008 TN 2004-2008 ME 1999-2008 TX 1999-2008 MD 199-2001, 2002-2008 VT 1999-2008 MA 1999-2008 VA 2003-2008 MI 1999-2008 WA 1999-2008 MN 1999-2008 WV 1999-2008 MS 2003-2008 WI 1999-2008 MO 1999-2008 WY 1999-2008
State Registry Ref Yr NPCR Ref Yr State Registry Ref Yr NPCR Ref Yr AL 1996 1996 MT 1979 1994 AK 1996 1996 NE 1987 1994 AZ 1981 1994 NV 1979 1994 AR 1996 1996 NH 1987 1994 CA 1988 1994 NJ 1979 1994 CO 1979 1994 NY 1979 1995 DE 1979 1997 NC 1985 1994 DC 1979 1995 ND 1997 1994 FL 1981 1994 OH 1992 1994 GA 1995 1995 OK 1995 1995 ID 1979 1994 OR 1996 1996 IL 1985 1994 PA 1982 1994 IN 1987 1994 RI 1987 1994 KS 1995 1995 SC 1994 1994 KY 1991 1994 SD 2001 2001 LA 1983 1994 TN 1983 1997 ME 1983 1994 TX 1979 1994 MD 1992 1995 VT 1994 1994 MA 1982 1994 VA 1979 1995 MI 1985 1994 WA 1992 1994 MN 1988 1994 WV 1993 1994 MS 1996 1996 WI 1979 1994 MO 1979 1994 WY 1979 1995
Percent case completeness estimated based on mortality data Electronic data edits Single field edits for valid code Inter-field edits for consistency Sex, primary site Date of last contact/death, vital status Inter-record edits for consistency among multiple primary sites Verify date of birth same on all records for a patient Verify vital status same on all records for a patient
Technical assistance provided by certified tumor registrars from CDC Training Registry software from CDC Data sharing agreements Case sharing across states - strong relationships between states where cancer patients regularly move across states (Florida, New York) Data Audits Central registries CDC
Compare data from medical records with central registry data file Also look for missed cases Over last 5 year time period, all registries audited once Central registry self-audits required a small number of cases each year
Investigating the Risk of Cancer in 1990 1991 US Gulf War Veterans With the Use of State Cancer Registry Data Ann Epidemiol. 2010 Apr;20(4):265-272.e1. Epub 2010 Jan 29 A combined healthy lifestyle score and risk of pancreatic cancer in a large cohort study. Arch Intern Med. 2009;169:764-70 Lung Cancer Risk Among Smokers of Menthol Cigarettes J Natl Cancer Inst. 2011;103:1 7 Methodological Issues in United States Retrospective Cancer Incidence Studies Am J Epidemiol. 2009;170:112 119
State-Level Mammography Utilization from 2000-2006 with Corresponding Breast Cancer Incidence Rates AJR Am J Roentgenol. 2009;192:352-60 Utilization of screening mammography in New Hampshire: a population-based assessment Cancer. 2005;104:1726 1732 Characteristics of adult osteosarcoma patients: Results from an ongoing postmarketing drug safety surveillance study Journal of Clinical Oncology, 2010 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 28, No 15_suppl (May 20 Supplement), 2010: 1608
Authorizing law requires that CCRs maintain a balance between releasing data for the purposes of cancer control and protecting the patients right of privacy.
Currently, laws and regulations regarding CCRs and the release of CCR data are mostly promulgated at the state level - impose additional requirements for review of research and informed consent when human subjects are involved - State statutes often overlap with the federal rules in conducting of human subjects research, but the scope, definitions, and standards of protection vary.
Result: One set of procedures for data use and confidentiality cannot be mandated for all locations. Consequence: Accessing CCR data for research, particular for multi-state CCR data is complicated and challenging.
Purposes: Gain understanding of comprehensive requirements and barriers of cancer registry data access for research. Identify optimal state/registry rules and policies. Investigate methods for streamlining the IRB processes and pilot test the best methods. Assist researchers in managing the process. Time line: Sept 21, 2010 Sept 20, 2013
Finished compilation on - federal and state level policies/regulations/rules for CCR data collection and access - state level IRB application requirements and contacts for access CCR data - state-specific step by step data access application instruction In the process of analysis and loading information into an interactive website. This website has two sites to serve the following purposes: Public site - Provide laws and regulation on cancer registry data collection and access to public and guide researchers step by step to apply and access statespecific CCR data Individual site - Assist researchers to manage multi-state CCR data access and IRB application process
Basic required documents from 48 states: Cancer registry data use application Study proposal/protocol List of data items needed Cancer Registry data use/confidentiality agreement In addition to basic requirements, special requirements for data access vary substantially among states
State specific Requirements 1. Initial cancer registry contact required prior to application submission 2. Allowance of releasing state residents identifiable data to researchers 3. Requirement of sponsorship from local researcher 4. Requirement of Cancer registry specific Human Subject Protection training Summary 45 states (including DC, US Pacific Islands and Puerto Rico) 48 states allowed after patient s consent 1 state only allows to release it to their own state health department researchers after patient s consent 3 states required local sponsorship 2 states indicated local sponsorship will make application easier 1 state required to be co author for publications 16 states required some type of Human Subject Protection training
State specific Requirements 5. IRB approval from requested state and/or researcher s affiliated institution 6. Pediatric research special requirements Summary 16 states required only IRB approval from researcher s affiliated institution 7 states required only IRB approval from registry affiliated institution 23 states required IRB approvals from both researcher s and registry affiliated institution 4 state required IRB approvals from registry affiliated institution but information was not available if IRB approval required from researcher affiliated institution 15 states have special requirements: 4states required parental and/or physician s consent 1 state required special section in application 1 state required cases by case review 1 state does not provide parents contact info 7 states indicated more difficult approval process required 1 states never handled pediatric study requests
State specific Requirements Summary Required consent: 26 states required patient consents 21 states required both physician and patients consents 3 state had no standards Consents can be passive or active 7. Patient contact and consent required for releasing of confidential data Who (including DC, US Pacific Islands and Puerto Rico) contacts patients: 16 states - the researcher does the contacting and consenting 15 states - the cancer registry does the contacting and consenting 12 states - the cancer registry does initial contact and researcher consents 4 states - have options on contact and consent
State specific Requirements 8. Level of detail and number of steps in the approval process Summary One level: 2 states only required Registry approval 2 states only required IRB approval 1 state only required Cancer Advisory group approval Two levels 14 states required Registry + IRB(s) approval 6 states required Registry + Cancer Advisory group(s ) approval 1 state required Cancer Advisory groups + IRB approval 2 states required State level officer(s) + IRB approval 2 states required Registry + State level officer(s) approval Three levels 13 states required Registry + Cancer Advisory groups + IRB approval 5 states required Registry + state level officer(s) +IRB approval
State specific Requirements 9. Frequency of IRB and other regulatory committee meetings 10. Charge of a fee/structure of the fee (IRB fee, data process fee, data linkage fee, etc.) 11. Timeframe for the approval process Summary Weekly: 2 states Monthly: 5 states Quarterly : 5 states Part time: 1 state 33 states will charge fees <2 months: 25 states 3 6 months: 16 states >6 months: 4 states Varied: 5 states (depends on available staff time, seasons, and complexity of case)
Christie Eheman Ceheman@CDC.Gov The findings and conclusions in this presentation are those of the presenter, and do not necessarily represent the official position of the Centers for Disease Control and Prevention