Grant Details
Grant Number: |
3U01CA164975-06S2 Interpret this number |
Primary Investigator: |
Platz, Elizabeth |
Organization: |
Johns Hopkins University |
Project Title: |
Enhancing Aric Infrastructure to Yield a New Cancer Epidemiology Cohort |
Fiscal Year: |
2018 |
Abstract
In this supplement application to U01 CA164975 under PAR-18-748 “Research Supplements to Promote Data
Sharing in Cancer Epidemiology Studies”, we propose to prepare, document, and submit cancer incidence,
mortality, and case-fatality data from the Atherosclerosis Risk in Communities study (ARIC) to NHLBI's
BioLINCC, a controlled-access database that contains the data from the parent ARIC study. Under the Cohort
Infrastructure mechanism, we enhanced ARIC's infrastructure making it a bona fide Cancer Epidemiology
Cohort with 4,743 incident primary cancer cases and 1,660 cancer deaths in 1987-2012. ARIC is a unique
cohort of 15,792 White and Black adults that began in 1987 when participants 45-64 years old were recruited
to be sex (55% female), race (27% Black), and geography (Forsyth Co., NC; Jackson, MS; Minneapolis, MN;
Washington Co., MD) diverse. ARIC's strengths for cancer research include measured anthropometric,
lifestyle, and medical data in clinical visits; calls to update data; repeated biospecimens and biomarkers; a
GWAS all consenting participants and other `omics on large subsets; linkage to Medicare (CMS) claims data;
and 30-year follow-up. Relevant to cancer survivorship, ARIC has extensively assessed cognitive and physical
function. As products of the U01, we generated an analytic case file for total cancer incidence and mortality,
and site-specific analytic case files for bladder, breast, colorectal, lung, pancreas, and prostate cancer that
contain site-specific variables to characterize the tumor, follow-up time variables, and covariates needed to
conduct high-quality cancer epidemiology analyses. For breast, colorectal, lung, and prostate cancers, the
analytic case files also include adjudicated case fatality. We prepared detailed documentation for each file and
developed sample SAS code and a macro that allows users to conduct visit-specific exposure updated survival
analyses. We documented the utility of these cancer data for ARIC Cancer's broad research agenda, for
collaborators, and consortia, by publications, conference abstracts, and approved ancillary studies and
manuscript proposals. To maximize ARIC Cancer's value to the scientific community independent of ARIC and
ARIC Cancer, while preserving confidentiality and being compliant with federal and state laws and regulations,
we propose to modify the datasets and documentation we prepared as follows: 1) remove data that cannot be
shared at an individual level, 2) remove or modify individual data that when crossed with ARIC data already
submitted to BioLINCC potentially could lead to participant identification, 3) de-identify the data, 4) revise
existing documentation to align with the revised data, 5) test the veracity of the de-identified data and
documentation by performing the statistical analysis of a previously approved study and comparing its results
to those when using the original dataset and documentation, 6) make final revisions to produce the final
dataset and documentation, and 7) provide these materials to the ARIC Coordinating Center for uploading into
BioLINCC as they do with the parent ARIC data. The work will be completed in 6 months.
Publications
None. See parent grant details.