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Journal of Translational Medicine
Published in: Journal of Translational Medicine 1/2012

Open Access 01-12-2012 | Review

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

Authors: David R Parkinson, Nicholas Dracopoli, Brenda Gumbs Petty, Carolyn Compton, Massimo Cristofanilli, Albert Deisseroth, Daniel F Hayes, Gordon Kapke, Prasanna Kumar, Jerry SH 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 Scher, Caroline C Sigman, Gary J Kelloff

Published in: Journal of Translational Medicine | Issue 1/2012

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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).
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Metadata
Title
Considerations in the development of circulating tumor cell technology for clinical use
Authors
David R Parkinson
Nicholas Dracopoli
Brenda Gumbs Petty
Carolyn Compton
Massimo Cristofanilli
Albert Deisseroth
Daniel F Hayes
Gordon Kapke
Prasanna Kumar
Jerry SH 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 Scher
Caroline C Sigman
Gary J Kelloff
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Journal of Translational Medicine / Issue 1/2012
Electronic ISSN: 1479-5876
DOI
https://doi.org/10.1186/1479-5876-10-138

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