Camp Lejeune Cancer Incidence Study (CIS): A retrospective cohort study Frank J. Bove, Sc.D, MS Agency for Toxic Substances and Disease Registry (ATSDR)/ Centers for Disease Control and Prevention (CDC) NAACCR/IACR Combined Annual Conference, June 13, 2019 Agency for Toxic Substances and Disease Registry

Researchers Principal Investigator: Contractor: Frank J. Bove, ScD, MS Agency for Toxic Substances and Disease Registry (ATSDR) / Centers for Disease Control and Prevention (CDC) Contractor: Battelle Memorial Institute Project Director: April Greek, PhD Project Manager: Ruth Gatiba, MPH

Researchers Subcontractors: North American Association of Central Cancer Registries Assistant Project Director: Betsy Kohler, MPH, CTR Recinda Sherman, MPH, PhD, CTR Castine Clerkin, MS, CTR Information Management Services, Inc. (IMS) Donald Green, BS William Howe, BS, BA University of Southern California –Los Angeles Rich Pinder, BA Dennis Deapen, PhD

Objectives Determine if exposures of marines and civilian workers to contaminated drinking water at Camp Lejeune were associated with increased risks of cancers. Did Camp Lejeune marines and workers have higher incidence rates for cancers than comparison cohorts of marines and workers? Within the Camp Lejeune cohorts, were there exposure-response relationships between cumulative exposures to the drinking water contaminants and increased incidence rates of cancers? This is a “data-linkage” study. There was no contact with the people in the study. The Defense Manpower Data Center (DMDC) data were used to identify the Camp Lejeune and Camp Pendleton cohorts.

Cohorts Marine/Navy personnel, 1975 - 1987 (N=521,154) Camp Lejeune = 241,513 Camp Pendleton = 256,697 New River Air Station = 22,944 Civilian employees, 1972 – 1987 (N=15,447) Camp Lejeune = 8,024 Camp Pendleton = 7,423 We are conducting a retrospective cohort study using cancer incidence and cause of death data. The purpose of the study is to determine whether exposures to drinking water contaminants at Camp Lejeune are associated with increased risk of specific cancers. This is a data linkage study that does not involve contact with cohort members. The study population of 536,631 cohort members consists of two cohorts at Camp Lejeune (Marines/Navy personnel and civilian employees) and comparison cohorts from Camp Pendleton. Those in the Camp Pendleton cohorts were never stationed or employed at Camp Lejeune during the period of drinking water contamination. Quarterly personnel data from the Defense Manpower Data Center (DMDC) were used to identify the Camp Lejeune and Camp Pendleton cohorts. Unit information necessary to determine where the Marines/Navy personnel were stationed first became available from the DMDC database in the second quarter of 1975. For the civilian employees, DMDC data on Department of Defense (DOD) employment began in the last quarter of 1972.  

Information Sources Defense Manpower Data Center personnel records Social security number, name, date of birth, sex, race, unit code, base location Camp Lejeune base family housing data Locator firm (TransUnion), Social Security Administration (SSA) data, and the National Death Index (NDI) Vital status, current address, state and date of death Personally identifiable information (PII) from the DMDC database that includes social security number; first, middle, and last names which are available for most subjects; date of birth; sex, and race will be used to determine the vital status of cohort members as of December 2017. Additionally, a locator firm will be used to obtain the current address for those who are determined to be alive through 2017. Cause of death information for all decedents, on both underlying and all contributing causes of death, will be obtained from the National Death Index (NDI). Information on the areas served by each drinking water system, the areas where units were barracked, family housing records and location of worksites will be used to assign exposures.

Cancer registry data Veterans Affairs Central Cancer Registry, Department of Defense Automated Central Tumor Registry, state and territorial cancer registries Cancer incidence data linked to personal identifier information Primary site SEER summary stage-1977 Histologic type Derived summary stage Laterality Sequence number Behavior code State of diagnosis Grade Age at diagnosis Diagnostic confirmation Date of diagnosis SEER summary stage-2000 “DCO” case (y/n) Data on all primary invasive cancers and in situ bladder cancers will be obtained via data linkage with federal (VACCR, DOD-ACTUR) and state cancer registries. ATSDR will provide the cancer registries with the PII, vital status, current address for those alive in 2017, and multiple (underlying and contributing) cause of death data and state and date of death for decedents for matching with their database. Each registry will be asked to provide cancer information to ATSDR linked to the cohort member’s PII used in the matching process. This table shows the data needed from each cancer registry.

Why national data? Camp Lejeune and Camp Pendleton cohorts reside in all 50 states and U.S. territories To minimize bias, registry data must be available for a high percentage (e.g., >90%) of both cohorts Comprehensive case ascertainment necessary for adequate statistical power since many cohort members will be <65 years old at end of follow-up To minimize bias, registry data must be available for a high percentage (e.g., >90%) of both cohorts – Camp Lejeune and Camp Pendleton Marines retire to different states Median age of marines (both at CL and CP) will be 59 years by the end of 2017. About 90% of CL marines will be under 65 years of age by the end of 2016. (87% of CP marines).

Analyses Comparisons between Camp Lejeune and Camp Pendleton cohorts January 1996 – December 2017 Comparisons internal to Camp Lejeune cohorts As far back as registry has complete data or January 1973, whichever is later, through December 2017 The Marines/Navy cohorts will be analyzed separately from the civilian worker cohorts because their drinking water exposure experiences were different Comparisons between CL and CP limited to 1996-2017 because almost all of the cancer registries were collecting data in 1996 For internal comparisons of the CL cohort, we can start follow up as early as 1973 because it will minimize bias due to incomplete ascertainment (bias will not likely be related to exposure)

Progress to date Applications submitted to 51 cancer registries Full approval received from 49 registries: 45 state registries VACCR, D.C., Puerto Rico, Pacific Island Jurisdiction

Next steps Obtain study approvals from remaining registries Obtain data security agreements and other materials from each registry prior to participation in the linkage Finalize agreements with TransUnion, SSA, and NDI to obtain current address and vital status information Each cancer registry performs linkage with cohort data

Questions?