The development of common data elements for a multi-institute prostate cancer tissue bank: The Cooperative Prostate Cancer Tissue Resource (CPCTR) experience

BACKGROUND: The Cooperative Prostate Cancer Tissue Resource (CPCTR) is a consortium of four geographically dispersed institutions that are funded by the U.S. National Cancer Institute (NCI) to provide clinically annotated prostate cancer tissue samples to researchers. To facilitate this effort, it was critical to arrive at agreed upon common data elements (CDEs) that could be used to collect demographic, pathologic, treatment and clinical outcome data. METHODS: The CPCTR investigators convened a CDE curation subcommittee to develop and implement CDEs for the annotation of collected prostate tissues. The draft CDEs were refined and progressively annotated to make them ISO 11179 compliant. The CDEs were implemented in the CPCTR database and tested using software query tools developed by the investigators. RESULTS: By collaborative consensus the CPCTR CDE subcommittee developed 145 data elements to annotate the tissue samples collected. These included for each case: 1) demographic data, 2) clinical history, 3) pathology specimen level elements to describe the staging, grading and other characteristics of individual surgical pathology cases, 4) tissue block level annotation critical to managing a virtual inventory of cases and facilitating case selection, and 5) clinical outcome data including treatment, recurrence and vital status. These elements have been used successfully to respond to over 60 requests by end-users for tissue, including paraffin blocks from cases with 5 to 10 years of follow up, tissue microarrays (TMAs), as well as frozen tissue collected prospectively for genomic profiling and genetic studies. The CPCTR CDEs have been fully implemented in two major tissue banks and have been shared with dozens of other tissue banking efforts. CONCLUSION: The freely available CDEs developed by the CPCTR are robust, based on "best practices" for tissue resources, and are ISO 11179 compliant. The process for CDE development described in this manuscript provides a framework model for other organ sites and has been used as a model for breast and melanoma tissue banking efforts

MS

thesisBorrelia burgdorferi produces potent cellular activating molecules capable of stimulating polyclonal proliferation and immunoglobulin production by murine B lymphocytes and cytokine production by a variety of cell types. These stimulatory molecules function in infected mice, resulting in elevated levels of circulating immunoglobulins and serum IL-6. We have recently demonstrated that the purified outer surface lipoproteins, OspA and OspB, possess these properties. To assess their possible involvement in human disease we determined if cells from normal human donors could respond to these activities. Normal human B lymphocytes, but not T lymphocytes, proliferated when incubated with either sonicated B. burgdorferi or with OspA. Sonicated B. burgdorferi was efficient at stimulating IgM production by human mononuclear cell cultures; however, purified OspA was relatively inactive. Both sonicated B. burgdorferi and purified OspA stimulated production of high levels of Il-6 by mononuclear cells. These findings extend our observation with the mouse, and suggest that the stimulatory lipoproteins could indeed be involved in the symptoms and pathologies of human disease. Furthermore, we hypothesized that the difference in cytokine levels in infected mice of different strains could relate to the difference in the IF-1 locus, which controls the production of IFN-?, IFN-?, TNF, IL-1 and IL-6. The IF-1 locus may control the response of cell of OSPA/B. So far, we have failed to detect differences in the response to OSPA/B between the cells from IF-1h and IF-1(1) strains. This may indicate a limitation to our method of analysis or a need to modify our hypothesis to include complex interactions occurring within the infected mouse

Clinical and epidemiological characteristics of imported dengue fever among inbound passengers: Infrared thermometer-based active surveillance at an international airport.

BackgroundDengue fever is endemic in tropical and subtropical areas, especially Southeast Asia. International air travel facilitates the spread of dengue across and within borders. To date, no predictive factors have been established for assessing risk of dengue among febrile travelers.MethodsSince 2006, Taiwan has operated a program of infrared thermometer-based non-contact active surveillance at Taoyuan International Airport (TPE). All inbound passengers from dengue-endemic countries who are febrile (tympanic temperature ≥38°C) undergo routine laboratory testing for dengue. We analyzed clinical and epidemiological characteristics of all tested passengers entering Taiwan via TPE in 2011 to identify the predictive factors of dengue infection.ResultsIn 2011, of the 3,719 febrile passengers from dengue-endemic countries, 74 (2.0%) had laboratory-confirmed dengue infection. Multivariable logistic regression analysis revealed that those who were aged ≥60 years (adjusted odds ratio [aOR], 8.7; 95% confidence interval [CI], 2.6-29.6) and had self-reported fever (aOR, 2.5; 95% CI, 1.5-4.1), skin rashes (aOR, 11.0; 95% CI, 3.4-35.1), or a tympanic temperature ≥39°C (aOR, 2.9; 95% CI, 1.7-4.9) were significantly more likely to have dengue (all p values ConclusionThese clinical and epidemiological features can facilitate timely recognition and diagnosis of imported dengue in febrile inbound passengers and therefore help prevent domestic transmission of dengue virus