Proficiency Testing to Assess Technical Performance for CTC-Processing and Detection Methods in CANCER-ID

Rui P.L. Neves, Wim Ammerlaan, Kiki C. Andree, Sebastian Bender, Laure Cayrefourcq, Christiane Driemel, Claudia Koch, Merlin Verena Luetke-Eversloh, Marianne Oulhen, Elisabetta Rossi, Catherine Alix-Panabières, Fay Betsou, Françoise Farace, Sabine Riethdorf, Thomas Schlange, Harriet Wikman, Rita Zamarchi, Klaus Pantel, Leon W.M.M. Terstappen, Nikolas H. StoeckleinCANCER-ID Consortium

Research output: Contribution to journalArticleResearchpeer-review

5 Citations (Scopus)

Abstract

BACKGROUND: Multiple technologies are available for detection of circulating tumor cells (CTCs), but standards to evaluate their technical performance are still lacking. This limits the applicability of CTC analysis in clinic routine. Therefore, in the context of the CANCER-ID consortium, we established a platform to assess technical validity of CTC detection methods in a European multi-center setting using non-small cell lung cancer (NSCLC) as a model. METHODS: We characterized multiple NSCLC cell lines to define cellular models distinct in their phenotype and molecular characteristics. Standardized tumor-cell-bearing blood samples were prepared at a central laboratory and sent to multiple European laboratories for processing according to standard operating procedures. The data were submitted via an online tool and centrally evaluated. Five CTC-enrichment technologies were tested. RESULTS: We could identify 2 cytokeratin expressing cell lines with distinct levels of EpCAM expression: NCI-H441 (EpCAMhigh, CKpos) and NCI-H1563 (EpCAMlow, CKpos). Both spiked tumor cell lines were detected by all technologies except for the CellSearch system that failed to enrich EpCAMlow NCI-H1563 cells. Mean recovery rates ranged between 49% and 75% for NCI-H411 and 32% and 76% for NCI-H1563 and significant differences were observed between the tested methods. CONCLUSIONS: This multi-national proficiency testing of CTC-enrichment technologies has importance in the establishment of guidelines for clinically applicable (pre)analytical workflows and the definition of minimal performance qualification requirements prior to clinical validation of technologies. It will remain in operation beyond the funding period of CANCER-ID in the context of the European Liquid Biopsy Society (ELBS).

Original languageEnglish
Pages (from-to)631-641
Number of pages11
JournalClinical Chemistry
Volume67
Issue number4
DOIs
Publication statusPublished - 31 Mar 2021

Keywords

  • CANCER-ID
  • CTC
  • Circulating Tumor Cells
  • enrichment
  • proficiency testing

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