Considerations in the development of circulating tumor cell technology for clinical use Journal Article
| Authors: | 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.; Scher, H. I.; Sigman, C. C.; Kelloff, G. J. |
| Article Title: | Considerations in the development of circulating tumor cell technology for clinical use |
| 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). © 2012 Parkinson et al.; licensee BioMed Central Ltd. |
| Keywords: | review; validation process; cancer diagnosis; biological marker; phenotype; tumor markers, biological; tumor biopsy; cancer cell culture; cell assay; prediction; neoplastic cells, circulating; laboratory test; medical technology; cell isolation; intermethod comparison; clinical effectiveness; metastasis potential; epithelial cell adhesion molecule; cytokeratin; good clinical practice; prognostic biomarker; circulating tumor cells; cd45 antigen; analytical validation; circulating tumor cell; clinical trial (topic); public-private partnership; cancer prognosis; predictive biomarker; clinical validation; biomarker qualification; oncologic drug development |
| Journal Title: | Journal of Translational Medicine |
| Volume: | 10 |
| Issue: | 1 |
| ISSN: | 1479-5876 |
| Publisher: | Biomed Central Ltd |
| Date Published: | 2012-07-01 |
| Start Page: | 138 |
| Language: | English |
| DOI: | 10.1186/1479-5876-10-138 |
| PROVIDER: | scopus |
| PMCID: | PMC3478228 |
| PUBMED: | 22747748 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 1" - "Export Date: 14 February 2013" - "Source: Scopus" |
