Considerations in the development of circulating tumor cell technology for clinical use

David R. Parkinson, Nicholas Dracopoli, Brenda G. Petty, Carolyn Compton, Massimo Cristofanilli, Albert Deisseroth, Daniel F. Hayes, Gordon Kapke, Prasanna Kumar, Jerry S.H. Lee, Minetta C. Liu, Robert McCormack, Stanislaw Mikulski, Larry Nagahara, Klaus Pantel, Sonia Pearson-White, Elizabeth A. Punnoose, Lori T. Roadcap, Andrew E. Schade, Howard I. ScherCaroline C. Sigman, Gary J. Kelloff

Research output: Contribution to journalReview article

231 Scopus citations

Abstract

This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC) technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker development-analytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA) and the US National Cancer Institute (NCI).

Original languageEnglish (US)
Article number138
JournalJournal of Translational Medicine
Volume10
Issue number1
DOIs
StatePublished - Jul 2 2012

Keywords

  • Analytical validation
  • Biomarker qualification
  • Circulating tumor cells
  • Clinical validation
  • Oncologic drug development
  • Predictive biomarker
  • Prognostic biomarker

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

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    Parkinson, D. R., Dracopoli, N., Petty, B. G., Compton, C., Cristofanilli, M., Deisseroth, A., Hayes, D. F., Kapke, G., Kumar, P., Lee, J. S. H., Liu, M. C., McCormack, R., Mikulski, S., Nagahara, L., Pantel, K., Pearson-White, S., Punnoose, E. A., Roadcap, L. T., Schade, A. E., ... Kelloff, G. J. (2012). Considerations in the development of circulating tumor cell technology for clinical use. Journal of Translational Medicine, 10(1), [138]. https://doi.org/10.1186/1479-5876-10-138