Edited bySudhir Srivastava, Ph.D., MPH Senior Scientific Officer, Chief, Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA Translational Oncology SeriesSeries EditorsROBERT C. BAST, MD, Vice President for Translational Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA MAURIE MARKMAN, MD, Senior Vice President for Clinical Affairs, Cancer Treatment Centers of America, Clinical Professor of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA ERNEST HAWK, MD, MPH, Vice President, Division of OVP, Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

• List of Contributors, ixPreface, xiiiPart I Foundations of Biomarker Research1 Nuts and Bolts of Biomarker Research, 3Sharmistha Ghosh and Sudhir Srivastava2 Cancer Genome Methylation: Biology, Biomarker and Therapeutic Opportunities, 16Shashwat Sharad, Taduru Sreenath, Shiv Srivastava, and Albert Dobi3 MicroRNA Biomarkers for Early Detection of Cancer, 27WendyWang, Matthew R Young, and Sudhir Srivastava4 Inflammation and Cancer, 37Pamela L Beatty, Sandra Cascio, and Olivera J Finn5 Exosomes: A Valuable Biomedical Tool in Biomarker Discovery and Development, 50Jocelyn Lee, Sharmistha Ghosh, and Sudhir Srivastava6 Epithelial-to-Mesenchymal Transition (EMT): Clinical Implications, 64Elisa CWoodhouse and Suresh MohlaPart II State-of-the-Science in Organ-Specific Biomarker Research7 Breast Cancer, 77Benjamin A Katchman, Christos Patriotis, and Karen S Anderson8 Ovarian Cancer, 93Christos Patriotis, Archana Simmons, Karen H Lu, Robert C Bast, Jr, and Steven J Skates9 Esophageal Cancer Biomarkers, 104Yanxin Luo, Kishore Guda, SanfordD Markowitz, Amitabh Chak, Andrew M Kaz, andWilliam M Grady10 Predictive Biomarkers for Therapy in Adenocarcinoma of the Upper Digestive Tract, 118Heath D Skinner, Qiongrong Chen, Elena Elimova, RoopmaWadhwa, Shumei Song, and Jaffer A Ajani11 Pancreatic Cancer, 130Sam CWang and Peter J Allen12 Colon Cancer, 141Paul DWagner13 Prognostic and Predictive Biomarkers for Colorectal Cancer, 151Upender Manne, Balananda-Dhurjati Kumar Putcha, Temesgen Samuel, and Sudhir Srivastava14 Early Detection of Lung Cancer, 163Mohamed Hassanein, Melinda C Aldrich, Stephen A Deppen, Karl E Krueger, Eric L Grogan, and Pierre P Massion15 Commonalities in Lung Cancer and COPD, 185MalgorzataWojtowicz and Eva Szabo16 Prostate Cancer, 197Jacob Kagan, Ian M Thompson, and DanielWChanPart III Biomarkers, Screening and Precision Health: Implications for Public Health17 Improving the Clinical Validity of Biomarker Research in Cancer Detection, 209David F Ransohoff18 Cancer Overdiagnosis, Ramifications and Research Strategies, 220Barbara K Dunn and Barnett S Kramer19 Predictive Markers and Driver Genes From Treatment Trials: Potential Utility For Early Diagnosis, 231Brian S Sorg, Sarfraz Memon, Kelly Y Kim, Aniruddha Ganguly, Tracy Lively, James Tricoli, Magdalena Thurin, Lokesh Agrawal, Tawnya C McKee, Barbara A Conley, and J Milburn Jessup20 Statistical Consideration in Predictive and Prognostic Markers, 245Fei Ye and Yu Shyr21 Clinical Validation of Molecular Biomarkers in Translational Medicine, 256Harry B Burke and William E Grizzle22 Cancer Biomarker Assays: Performance Standards, 267Anna K Fuzery and Daniel W Chan23 Bioethics and Cancer Biomarker Research, 277Nathan Nobis, William Grizzle, and Stephen Sodeke24 Colon Cancer Screening, 283Molly Perencevich, Jennifer Inra, and Sapna Syngal