Core 2: Clinical and Tissue Core

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Project Summary (Core 2) Modern biomedical research is being transformed by what is increasingly becoming a flood of information. Electronic medical records have opened unprecedented opportunities for studies investigating a wide range of problems ranging from epidemiological aspects of human disease to the comparative effectiveness of various treatment protocols. Similarly, genomic technologies such as next-generation DNA and RNA sequencing have opened a floodgate of data and information that promises to shed light on the complex nature of human disease. In this information-rich age, one of the greatest challenges is therefore no longer generating data, but effectively integrating it so that it can be used to advantage. Because clinical practice has long been separate from the research enterprise at most academic health centers, a situation has evolved in which clinical and research data exist in separate, often incompatible domains with a variety of technical, institutional, and organizational barriers between them. Further limiting our ability to extract the maximal value of the data we have available is the fact that data within institutions is rarely integrated with the vast body of data available in the public domain. Similarly, another need is to aid Investigators better characterize and identify tumor biologic and molecular genetic correlates for response, progression, and survival by collecting, preserving and distributing tissue derived from patients on clinical protocol. A large sources of clinical data will be used in this program project. The data for this large IFM/DFCI collaborative clinical trials (1260 MM patients, following induction HDT and consolidation, achieving minimal residual disease will be randomized to lenalidomide with or without daratumumab) are collected in an established clinical trials database at the IFM and DFCI. The aims of Core B are to create, maintain, and quality control the clinical database (Specific Aim 1); to collect, transport, process and store tissue samples from all sites utilizing standardized procedures in centralized tissue banks (Specific Aim 2); and to develop an integrated database to integrate the sample tracking and oncogenomic information with the relevant clinical data from the clinical trials database with web based query capabilities (Specific Aim 3).