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Tumor Markers: Development and Use in Clinical Oncology Richard L. Schilsky and Sheila Taube, Guest Editors June 2002 Introduction: Tumor Markers as Clinical Cancer Tests—Are We There Yet? Richard L. Schilsky and Sheila Taube Issues and Barriers to Development of Clinically Useful Tumor Markers: A Development Pathway Proposal M. Elizabeth H. Hammond and Sheila E. Taube Issues in Clinical Trial Design for Tumor Marker Studies Daniel Sargent and Carmen Allegra c-erbB-2 in Breast Cancer: Development of a Clinically Useful Marker Daniel F. Hayes and Ann D. Thor P53 Gene Mutations: Case Study of a Clinical Marker for Solid Tumors Minetta C. Liu and Edward P. Gelmann Clinical Translation of Gene Expression Profiling in Lymphomas and Leukemias Andreas Rosenwald and Louis M. Staudt Prostate-Specific Antigen in Prostate Cancer: A Case Study in the Development of a Tumor Marker to Monitor Recurrence and Assess Response Eric J. Small and Mack Roach III Pathological and Molecular Assessment of Sentinal Lymph Nodes in Solid Tumors David Krag and Donald L. Weaver Challenges in Developing a Molecular Characterization of Cancer Jonathan R. Pollack, Matt van de Rijn, and David Botstein Doctor’s Dilemma: Incorporating Tumor Markers Into Clinical Decision-Making Christina M. Canil and Ian F. Tannock Regulatory Issues in Tumor Marker Development Steven Gutman Forthcoming Issue

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Page 1: Forthcoming Issue

Tumor Markers: Development and Use in Clinical OncologyRichard L. Schilsky and Sheila Taube, Guest Editors

June 2002

Introduction: Tumor Markers as Clinical Cancer Tests—Are We There Yet? Richard L. Schilsky andSheila Taube

Issues and Barriers to Development of Clinically Useful Tumor Markers:A Development Pathway Proposal M. Elizabeth H. Hammond and Sheila E. Taube

Issues in Clinical Trial Design for Tumor Marker Studies Daniel Sargent and Carmen Allegra

c-erbB-2 in Breast Cancer: Development of a Clinically Useful Marker Daniel F. Hayesand Ann D. Thor

P53 Gene Mutations: Case Study of a Clinical Marker for Solid Tumors Minetta C. Liu andEdward P. Gelmann

Clinical Translation of Gene Expression Profiling in Lymphomas and Leukemias Andreas Rosenwaldand Louis M. Staudt

Prostate-Specific Antigen in Prostate Cancer: A Case Study in the Development of a Tumor Markerto Monitor Recurrence and Assess Response Eric J. Small and Mack Roach III

Pathological and Molecular Assessment of Sentinal Lymph Nodes in Solid Tumors David Krag andDonald L. Weaver

Challenges in Developing a Molecular Characterization of Cancer Jonathan R. Pollack,Matt van de Rijn, and David Botstein

Doctor’s Dilemma: Incorporating Tumor Markers Into Clinical Decision-Making Christina M. Caniland Ian F. Tannock

Regulatory Issues in Tumor Marker Development Steven Gutman

Forthcoming Issue