© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 14, 1054-1061,
July 18, 2001
© 2001 Oxford University Press
COMMENTARY |
Phases of Biomarker Development for Early Detection of Cancer
Affiliations of authors: M. S. Pepe, Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle; M. L. Thompson, Department of Biostatistics, University of Washington; R. Etzioni, Z. Feng, J. D. Potter, M. Thornquist, M. Winget, Y. Yasui, Fred Hutchinson Cancer Research Center.
Correspondence to: Margaret Sullivan Pepe, Ph.D., Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195–7232 (e-mail: mspepe@u.washington.edu).
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1) INTRODUCTION |
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Recent developments in such areas of research as gene-expression microarrays, proteomics, and immunology offer new approaches to cancer screening (1). The surge in research to develop cancer-screening biomarkers prompted the establishment of the Early Detection Research Network (EDRN) by the National Cancer Institute (2). The purpose of the EDRN is to coordinate research among biomarker-development laboratories, biomarker-validation laboratories, clinical repositories, and population-screening programs. By coordination of research efforts, the hope is to facilitate collaboration and to promote efficiency and rigor in research.
With the goals of the EDRN in mind, the purpose of this commentary is to define a formal structure to guide the process of biomarker development. We categorize the development into five phases that a biomarker needs to pass through to produce a useful population-screening tool. The phases of research are generally ordered according to the strength of evidence that each provides in favor
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2) OBJECTIVES OF POPULATION SCREENING |
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3) FIVE PHASES OF SCREENING BIOMARKER DEVELOPMENT |
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3.1) Phase 1—Preclinical Exploratory Studies
Primary Aims Specimen Selection Primary Outcome Measures Evaluation of Study Results Sample Sizes 3.2) Phase 2—Clinical Assay Development for Clinical Disease
Primary Aim Secondary Aims Specimen Selection Primary Outcome Measure Evaluation of Study Results Sample Sizes 3.3) Phase 3—Retrospective Longitudinal Repository Studies
Primary Aims Secondary Aims Specimen Selection Primary Outcome Measure Evaluation of Study Results: an Example Sample Sizes 3.4) Phase 4—Prospective Screening Studies
Primary Aim Secondary Aims Subject Selection Primary Outcome Measure Evaluation of Study Results Sample Size 3.5) Phase 5—Cancer Control Studies
Primary Aim Secondary Aims Subject Selection Primary Outcome Measure Evaluation of Study Results Sample Size
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4) DISCUSSION |
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NOTES |
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REFERENCES |
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M. Winget, H. Kincaid, P. Lin, L. Li, S. Kelly, and M. Thornquist A web-based system for managing and co-ordinating multiple multisite studies Clinical Trials, February 1, 2005; 2(1): 42 - 49. [Abstract] [PDF]
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H. Zhang, E. C. Yi, X.-j. Li, P. Mallick, K. S. Kelly-Spratt, C. D. Masselon, D. G. Camp II, R. D. Smith, C. J. Kemp, and R. Aebersold High Throughput Quantitative Analysis of Serum Proteins Using Glycopeptide Capture and Liquid Chromatography Mass Spectrometry Mol. Cell. Proteomics, February 1, 2005; 4(2): 144 - 155. [Abstract] [Full Text] [PDF]
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O. J. Semmes, Z. Feng, B.-L. Adam, L. L. Banez, W. L. Bigbee, D. Campos, L. H. Cazares, D. W. Chan, W. E. Grizzle, E. Izbicka, et al. Evaluation of Serum Protein Profiling by Surface-Enhanced Laser Desorption/Ionization Time-of-Flight Mass Spectrometry for the Detection of Prostate Cancer: I. Assessment of Platform Reproducibility Clin. Chem., January 1, 2005; 51(1): 102 - 112. [Abstract] [Full Text] [PDF]
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Y. Li, M. A. R. St. John, X. Zhou, Y. Kim, U. Sinha, R. C. K. Jordan, D. Eisele, E. Abemayor, D. Elashoff, N.-H. Park, et al. Salivary Transcriptome Diagnostics for Oral Cancer Detection Clin. Cancer Res., December 15, 2004; 10(24): 8442 - 8450. [Abstract] [Full Text] [PDF]
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O. J. Semmes Defining the Role of Mass Spectrometry in Cancer Diagnostics Cancer Epidemiol. Biomarkers Prev., October 1, 2004; 13(10): 1555 - 1557. [Full Text] [PDF]
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 J. P. Jakupciak, W. Wang, P. E. Barker, S. Srivastava, and D. H. Atha Analytical Validation of Telomerase Activity for Cancer Early Detection: TRAP/PCR-CE and hTERT mRNA Quantification Assay for High-Throughput Screening of Tumor Cells J. Mol. Diagn., August 1, 2004; 6(3): 157 - 165. [Abstract] [Full Text]
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 M. A. R. St. John, Y. Li, X. Zhou, P. Denny, C.-M. Ho, C. Montemagno, W. Shi, F. Qi, B. Wu, U. Sinha, et al. Interleukin 6 and Interleukin 8 as Potential Biomarkers for Oral Cavity and Oropharyngeal Squamous Cell Carcinoma Arch Otolaryngol Head Neck Surg, August 1, 2004; 130(8): 929 - 935. [Abstract] [Full Text] [PDF]
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R. A. Sharma and P. B. Farmer Biological Relevance of Adduct Detection to the Chemoprevention of Cancer Clin. Cancer Res., August 1, 2004; 10(15): 4901 - 4912. [Abstract] [Full Text] [PDF]
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 S. M. Hewitt, J. Dear, and R. A. Star Discovery of Protein Biomarkers for Renal Diseases J. Am. Soc. Nephrol., July 1, 2004; 15(7): 1677 - 1689. [Abstract] [Full Text] [PDF]
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J. D. Potter Toward the Last Cohort Cancer Epidemiol. Biomarkers Prev., June 1, 2004; 13(6): 895 - 897. [Full Text] [PDF]
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 P. Maruvada and S. Srivastava Biomarkers for Cancer Diagnosis: Implications for Nutritional Research J. Nutr., June 1, 2004; 134(6): 1640S - 1645S. [Abstract] [Full Text] [PDF]
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 I. M. Thompson, D. K. Pauler, P. J. Goodman, C. M. Tangen, M. S. Lucia, H. L. Parnes, L. M. Minasian, L. G. Ford, S. M. Lippman, E. D. Crawford, et al. Prevalence of Prostate Cancer among Men with a Prostate-Specific Antigen Level <=4.0 ng per Milliliter N. Engl. J. Med., May 27, 2004; 350(22): 2239 - 2246. [Abstract] [Full Text] [PDF]
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