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

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 step...

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Published inJournal of translational medicine Vol. 10; no. 1; p. 138
Main Authors Parkinson, David R, Dracopoli, Nicholas, Petty, Brenda Gumbs, Compton, Carolyn, Cristofanilli, Massimo, Deisseroth, Albert, Hayes, Daniel F, Kapke, Gordon, Kumar, Prasanna, Lee, Jerry Sh, Liu, Minetta C, McCormack, Robert, Mikulski, Stanislaw, Nagahara, Larry, Pantel, Klaus, Pearson-White, Sonia, Punnoose, Elizabeth A, Roadcap, Lori T, Schade, Andrew E, Scher, Howard I, Sigman, Caroline C, Kelloff, Gary J
Format Journal Article
LanguageEnglish
Published England BioMed Central Ltd 02.07.2012
BioMed Central
BMC
Subjects
Analytical validation
Biomarker qualification
Biomarkers
Biomarkers, Tumor
Biomedical research
Cancer
Care and treatment
Circulating tumor cells
Clinical validation
Critical path
Diagnosis
Humans
Inventors
Metastasis
Neoplastic Cells, Circulating
Oncologic drug development
Pharmaceutical industry
Predictive biomarker
Prognosis
Prognostic biomarker
Public-private sector cooperation
Review
Technological change
Technology application
Tumors
Philadelphia Pennsylvania
South San Francisco California
Ann Arbor Michigan
Indianapolis Indiana
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Summary: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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ISSN:1479-5876
1479-5876
DOI:10.1186/1479-5876-10-138