Table of Contents

INTRODUCTION TO SURROGATE TISSUE ANALYSIS. Introduction to Surrogate Tissue Analysis. GENOMIC APPROACHES. Impact of Sample Handling and Preparation on Gene Signatures as Exemplified for Transcriptome Analysis of Peripheral Blood. Blood Genomic Fingerprints of Brain Diseases. Transcriptional Profiling of Peripheral Blood in Oncology. Blood-Derived Transcriptomic Profiles as a Means to Monitor Levels of Toxicant Exposure and the Effects of Toxicants on Inaccessible Target Tissues. Spermatozoal RNAs as Surrogate Markers of Paternal Exposure. PROTEOMIC APPROACHES. Proteomic Analysis of Surrogate Tissues: Mass Spectrometry-Based Profiling of the Circulatory Proteome for Cancer Detection and Stratification. Lymphocyte Integrins: Potential Surrogate Biomarkers for Evaluation of Endometrial Receptivity. Nipple Aspirate Fluid to Diagnose Breast Cancer and Monitor Response to Treatment. METABOLOMICS AND OTHER APPROACHES. Metabonomics: Metabolic Profiling and Pattern Recognition Analysis of Body Fluids and Tissues for Characterization of Drug Toxicity and Disease Diagnosis. Comprehensive Metabolomic Profiling of Serum and Cerebrospinal Fluid: Understanding Disease, Human Variability, and Toxicity. Lipidomic Analysis of Plasma and Tissues: Lipid-Derived Mediators of Inflammation and Markers of Disease. Molecular Detection and Characterization of Circulating Tumor Cells and Micrometastases in Solid Tumors. Methylation Profiling of Tumor Cells and Tumor DNA in Blood, Urine, and Body Fluids for Cancer Detection and Monitoring. FUTURE CONSIDERATIONS FOR SURROGATE TISSUE PROFILING. Regulatory and Technical Challenges in Incorporating Surrogate Tissue Profiling Strategies into Clinical Development Programs. Considerations in the Economic Assessment of the Value of Molecular Profiling. The Impact and Challenges of Pan-Omic Approaches in Pharmaceutical Discovery and Development. Current and Future Aspects of Surrogate Tissue Analysis. References.

About the Author

Michael E. Burczynski, John C. Rockett

Reviews

"In summary, the editors and their coauthors have done a very
creditable job of expressing the breadth of the field of surrogate
tissue analysis and provide many concrete examples of techniques
for analysis. The treatment of this arising technology is
at once learned and practical with examples of success and of
the need for further research. The chapters at the end with perspective setting essays on economic and regulatory needs may
help some not accustomed to these issues to understand the issues.
However, the lesson to take away from this text is the great
possibilities that exist to sharpen our view of biology and of
medicine in particular. Future progress will involve refinement
of the methods described here. There are methods that will not
stand the test of time but taken as a whole, this book should
be widely read. Every chapter has extensive bibliographic references
and should serve as entrée into the literature even if the
specific examples are of only passing interest. The editors and
their coauthors are to be commended in providing a very thorough
and interesting sampling of the methods being developed
in the field."
Sid Aaron, Sid Aaron Consultants, LLC, in the International Journal of Toxicology, May 2006