Abstract
Abstract Successful implementation of personalized health care requires the availability of biospecimens of sufficient quality to ensure accurate downstream test results, which will in turn determine optimal patient management. Cancer biospecimens of known quality with appropriate clinical annotation are also critical to the process of biomarker discovery and validation that lead to the development of clinical tests. Due to widely varying methods of biospecimen collection, processing, and storage, numerous pre-analytical factors can affect human biospecimen integrity for biomarker research. Such pre-analytical variability can affect the integrity of research biospecimens including plasma/serum and fixed cancer tissues used for biomarker analysis. The National Cancer Institute (NCI) Biorepositories and Biospecimen Research Branch (BBRB) was established to address the scientific and policy issues that affect the procurement of and access to high quality specimens for research. The NCI Biospecimen Research Network (BRN) was established to sponsor and conduct research on biospecimen pre-analytical factors and their affect on molecular integrity, to support the development and adoption of evidence-based standardized biospecimen handling procedures. In this presentation we will summarize BRN-supported studies to identify biomarkers that may be used as sentinel markers of plasma stability using mass spectroscopy proteomics and analysis of circulating miRNA, and the development of intrinsic controls for FFPE tissues. In one of the projects, identification of protein biomarkers using mass-spectrometry and Illumina arrays in plasma led to the development of a biomarker panel for serum/plasma integrity; these biomarkers are currently being validated. A second project studied the effects of pre-analytical variables on circulating miRNA and identified and validated new and improved housekeeping miRNA, as well as novel biomarkers associated with breast cancer. In another study, a series of biomarkers have been validated by construction of tissue microarrays from 93 breast cancer specimens with known time to fixation delays. A tissue quality index (TQI) model was generated to predict the time to fixation and tissue quality by measuring a subset of biomarker proteins in breast cancer tissues using AQUA technology. The progressive efforts taken by BRN investigator-led projects to identify and validate biomarkers for sample integrity will be incorporated into efforts to develop new biospecimen evidence-based practices for clinical biomarker research. Citation Format: Lokesh Agrawal, Jim Vaught, Helen Moore. Molecular biomarkers for cancer biospecimen integrity. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 2493. doi:10.1158/1538-7445.AM2014-2493
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