ABSTRACT
ABSTRACT Biomarkers have gained immense clinical importance because of their wide spectrum in early detection, diagnosis, prevention, and treatment of cancer. Before diagnosis, biomarkers are used for risk assessment, screening, and follow-up prevention. During diagnosis, biomarkers are used for staging and grading of tumor/cancer, and during prognosis (the course of treatment), biomarkers play an important role for determination of initial therapy, treatment response, and clinical outcome. With recent advances in genomics, epigenomics, and proteomics and with the use of high-throughput technologies, a plethora of new candidate biomarkers have been recognized. Despite major scientic achievements, only a few of these biomarkers have been translated into clinical practice especially in the eld of carcinogenesis. A number of barriers such as poor quality control and lack of samples for validating and testing
Abbreviations ............................................................................................................................................. 4 1.1 Introduction ...................................................................................................................................... 5 1.2 Sensitivity and Specicity of Cancer Biomarkers ........................................................................... 5 1.3 Phases of Biomarker Development .................................................................................................. 6
1.3.1 Preclinical Phase or Phase 1 ................................................................................................ 6 1.3.2 Phase 2 Studies .................................................................................................................... 6 1.3.3 Phase 3 ................................................................................................................................. 6 1.3.4 Phase 4 ................................................................................................................................. 7 1.3.5 Phase 5 Studies/Cancer Control Studies ............................................................................. 7 1.3.6 Biomarker Discovery Using High-Throughput Technology ............................................... 7
1.4 Quality Control ................................................................................................................................ 8 1.5 Quality Assurance ........................................................................................................................... 9 1.6 Biomarker Method Validation ......................................................................................................... 9 1.7 Standardization/Validation through Collaboration ....................................................................... 10 1.8 Biomarkers into Drug Development ...............................................................................................11 1.9 Ethical Considerations in the Development of Cancer Biomarkers ...............................................11
