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

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

doi:10.1186/1479-5876-10-138

Cited by 296 publications

(310 citation statements)

References 61 publications

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“…The challenge is to capture them with a high efficiency and high purity, despite their extreme rarity and high phenotype heterogeneity [1][2][3][4][5][6][7][8][9][10] . Currently, two approaches are in competition, depending on whether or not the capture is affinity-based.…”

mentioning

confidence: 99%

Microfluidic device with integrated microfilter of conical-shaped holes for high efficiency and high purity capture of circulating tumor cells

Tang

Shi

et al. 2014

Sci Rep

137

104

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Capture of circulating tumor cells (CTCs) from peripheral blood of cancer patients has major implications for metastatic detection and therapy analyses. Here we demonstrated a microfluidic device for high efficiency and high purity capture of CTCs. The key novelty of this approach lies on the integration of a microfilter with conical-shaped holes and a micro-injector with cross-flow components for size dependent capture of tumor cells without significant retention of non-tumor cells. Under conditions of constant flow rate, tumor cells spiked into phosphate buffered saline could be recovered and then cultured for further analyses. When tumor cells were spiked in blood of healthy donors, they could also be recovered at high efficiency and high clearance efficiency of white blood cells. When the same device was used for clinical validation, CTCs could be detected in blood samples of cancer patients but not in that of healthy donors. Finally, the capture efficiency of tumor cells is cell-type dependent but the hole size of the filter should be more closely correlated to the nuclei size of the tumor cells. Together with the advantage of easy operation, low-cost and high potential of integration, this approach offers unprecedented opportunities for metastatic detection and cancer treatment monitoring.C irculating tumor cells (CTCs) in peripheral blood of cancer patients are reliable biomarkers for metastatic detection and treatment monitoring. The challenge is to capture them with a high efficiency and high purity, despite their extreme rarity and high phenotype heterogeneity [1][2][3][4][5][6][7][8][9][10] . Currently, two approaches are in competition, depending on whether or not the capture is affinity-based. The affinity-based capture relies on immunochemical interaction between magnetic beads [11][12][13][14][15][16] or patterned structures [17][18][19][20] and tumor cells that express special surface markers such as EpCAM, an epithelial cell adhesion molecule over expressed by majority of tumor cells. These methods are efficient for capturing CTCs of epithelial phenotypes but not applicable to those with down-regulated or lost epithelial markers. Indeed, it is known that tumor cells of epithelial origin may undergo epithelial to mesenchymal transition 21,22 . In contrast, the non-affinity methods, including centrifuging deflection [23][24][25][26][27] , dielectrophoretic separation [28][29][30] and size-based filtration 12,[31][32][33][34][35][36][37][38][39][40][41][42][43][44] , are able to isolate both epithelial and mesenchymal phenotypes, which are more appropriate for analyses of tumor heterogeneity, tumor drug resistance, etc. However, these approaches are technologically biased and it is often difficult to reach a trade-off between capture efficiency, purity and cell viability which are all important criteria for both fundamental and clinical studies. For example, the size-based filtration has been developed for more than several decades but the most of reported results were obtained by using track-etche...

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mentioning

confidence: 99%

Microfluidic device with integrated microfilter of conical-shaped holes for high efficiency and high purity capture of circulating tumor cells

Tang

Shi

et al. 2014

Sci Rep

137

104

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“…The CTCs extravasate into the bloodstream and circulate; they may form secondary metastases, self‐seed, or remain in the circulatory system until clearance 10, 11, 12, 13. These cells are an accessible source of nonhematological tumor cells and, along with circulating nucleic acids, are components of what are termed liquid biopsies, which are increasingly being recognized as potentially valuable noninvasive tools for temporal characterization of a patient's tumor (including the constituent heterogeneity), because they can be isolated and characterized from a noninvasive blood draw 14, 15.…”

Section: Multiparameter Characterization Of Circulating Vs Solid Tummentioning

confidence: 99%

“…Multiplex protein expression (4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37) …”

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confidence: 99%

Opportunities and Challenges in Implementation of Multiparameter Single Cell Analysis Platforms for Clinical Translation

Keating

Taylor

Plant

et al. 2018

Clinical Translational Sci

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The high‐content interrogation of single cells with platforms optimized for the multiparameter characterization of cells in liquid and solid biopsy samples can enable characterization of heterogeneous populations of cells ex vivo. Doing so will advance the diagnosis, prognosis, and treatment of cancer and other diseases. However, it is important to understand the unique issues in resolving heterogeneity and variability at the single cell level before navigating the validation and regulatory requirements in order for these technologies to impact patient care. Since 2013, leading experts representing industry, academia, and government have been brought together as part of the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium to foster the potential of high‐content data integration for clinical translation.

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“…There is growing concern that ctDNA analysis may follow the same path as first‐generation CTC methods4 because the data needed to demonstrate the level of evidence that the FDA and payers believe is needed for clinical efficacy currently exists for only the two indications just mentioned. While many blood profiling platforms exist for research use only (RUO), questions remain regarding the performance characteristics and clinical validation of these platforms, and standard protocols for sample collection, processing, and analysis remain to be established.…”

mentioning

confidence: 99%

Collaborating to Compete: Blood Profiling Atlas in Cancer (BloodPAC) Consortium

Grossman

Abel

Angiuoli

et al. 2017

Clin Pharma and Therapeutics

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The cancer community understands the value of blood profiling measurements in assessing and monitoring cancer. We describe an effort among academic, government, biotechnology, diagnostic, and pharmaceutical companies called the Blood Profiling Atlas in Cancer (BloodPAC) Project. BloodPAC will aggregate, make freely available, and harmonize for further analyses, raw datasets, relevant associated clinical data (e.g., clinical diagnosis, treatment history, and outcomes), and sample preparation and handling protocols to accelerate the development of blood profiling assays.

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

Cited by 296 publications

References 61 publications

Microfluidic device with integrated microfilter of conical-shaped holes for high efficiency and high purity capture of circulating tumor cells

Microfluidic device with integrated microfilter of conical-shaped holes for high efficiency and high purity capture of circulating tumor cells

Opportunities and Challenges in Implementation of Multiparameter Single Cell Analysis Platforms for Clinical Translation

Collaborating to Compete: Blood Profiling Atlas in Cancer (BloodPAC) Consortium

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