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

Rui P L Neves1, Wim Ammerlaan2, Kiki C Andree3

  • 1Department of General, Visceral and Paediatric Surgery, University Hospital and Medical Faculty of the Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.

Clinical Chemistry
|January 25, 2021
PubMed
Summary
This summary is machine-generated.

Standardized testing of circulating tumor cell (CTC) detection technologies is crucial for clinical application. This study evaluated multiple CTC enrichment methods using non-small cell lung cancer models, revealing significant performance differences and the need for established guidelines.

Keywords:
CANCER-IDCTCCirculating Tumor Cellsenrichmentproficiency testing

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Area of Science:

  • Oncology
  • Biotechnology
  • Clinical Diagnostics

Background:

  • Standardized evaluation methods for circulating tumor cell (CTC) detection technologies are lacking, hindering clinical routine application.
  • The CANCER-ID consortium established a platform for multi-center technical validation of CTC detection in non-small cell lung cancer (NSCLC).

Purpose of the Study:

  • To assess the technical validity of various CTC detection technologies in a European multi-center setting.
  • To establish standardized workflows and performance requirements for clinically applicable CTC analysis.

Main Methods:

  • Characterization of NSCLC cell lines with distinct phenotypes and molecular markers (EpCAM expression).
  • Preparation and distribution of standardized tumor-cell-bearing blood samples to multiple European laboratories.
  • Testing of five CTC-enrichment technologies using standardized operating procedures and central data evaluation.

Main Results:

  • Two cytokeratin-positive NSCLC cell lines (NCI-H441, EpCAMhigh; NCI-H1563, EpCAMlow) were used as models.
  • All tested technologies detected NCI-H441 cells, but only some detected NCI-H1563 cells, with the CellSearch system failing to enrich EpCAMlow cells.
  • Mean recovery rates varied significantly between methods, ranging from 49% to 75% for NCI-H441 and 32% to 76% for NCI-H1563.

Conclusions:

  • Multi-national proficiency testing is vital for establishing guidelines for pre-analytical workflows in CTC analysis.
  • Defining minimal performance qualification requirements is essential before clinical validation of CTC detection technologies.
  • The established platform will continue operation under the European Liquid Biopsy Society (ELBS) to support ongoing standardization efforts.