Dimple Y Chudasama1, Daria V Freydina2, Maxim B Freidin2, Maria Leung2, Angeles Montero Fernandez3, Alexandra Rice3, Andrew G Nicholson3, Emmanouil Karteris4, Vladimir Anikin5, Eric Lim2. 1. National Heart and Lung Institute, Imperial College London, London, UK;; Division of Thoracic Surgery, Harefield Hospital, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, UK;; Division of Biosciences, Brunel University London, London, UK. 2. National Heart and Lung Institute, Imperial College London, London, UK;; Academic Division of Thoracic Surgery, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, UK. 3. National Heart and Lung Institute, Imperial College London, London, UK;; Department of Histopathology, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, UK. 4. Division of Biosciences, Brunel University London, London, UK. 5. Division of Thoracic Surgery, Harefield Hospital, The Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, UK.
Abstract
BACKGROUND: Routine clinical application of circulating tumour cells (CTCs) for blood based diagnostics is yet to be established. Despite growing evidence of their clinical utility for diagnosis, prognosis and treatment monitoring, the efficacy of a robust platform and universally accepted diagnostic criteria remain uncertain. We evaluate the diagnostic performance of a microfluidic CTC isolation platform using cytomorphologic criteria in patients undergoing lung cancer surgery. METHODS: Blood was processed from 51 patients undergoing surgery for known or suspected lung cancer using the ClearBridge ClearCell FX systemTM (ClearBridge Biomedics, Singapore). Captured cells were stained on slides with haematoxylin and eosin (H&E) and independently assessed by two pathologist teams. Diagnostic performance was evaluated against the pathologists reported diagnosis of cancer from surgically obtained specimens. RESULTS: Cancer was diagnosed in 43.1% and 54.9% of all cases. In early stage primary lung cancer, between the two reporting teams, a positive diagnosis of CTCs was made for 50% and 66.7% of patients. The agreement between the reporting teams was 80.4%, corresponding to a kappa-statistic of 0.61±0.11 (P<0.001), indicating substantial agreement. Sensitivity levels for the two teams were calculated as 59% (95% CI, 41-76%) and 41% (95% CI, 24-59%), with a specificity of 53% for both. CONCLUSIONS: The performance of the tested microfluidic antibody independent device to capture CTCs using standard cytomorphological criteria provides the potential of a diagnostic blood test for lung cancer.
BACKGROUND: Routine clinical application of circulating tumour cells (CTCs) for blood based diagnostics is yet to be established. Despite growing evidence of their clinical utility for diagnosis, prognosis and treatment monitoring, the efficacy of a robust platform and universally accepted diagnostic criteria remain uncertain. We evaluate the diagnostic performance of a microfluidic CTC isolation platform using cytomorphologic criteria in patients undergoing lung cancer surgery. METHODS: Blood was processed from 51 patients undergoing surgery for known or suspected lung cancer using the ClearBridge ClearCell FX systemTM (ClearBridge Biomedics, Singapore). Captured cells were stained on slides with haematoxylin and eosin (H&E) and independently assessed by two pathologist teams. Diagnostic performance was evaluated against the pathologists reported diagnosis of cancer from surgically obtained specimens. RESULTS:Cancer was diagnosed in 43.1% and 54.9% of all cases. In early stage primary lung cancer, between the two reporting teams, a positive diagnosis of CTCs was made for 50% and 66.7% of patients. The agreement between the reporting teams was 80.4%, corresponding to a kappa-statistic of 0.61±0.11 (P<0.001), indicating substantial agreement. Sensitivity levels for the two teams were calculated as 59% (95% CI, 41-76%) and 41% (95% CI, 24-59%), with a specificity of 53% for both. CONCLUSIONS: The performance of the tested microfluidic antibody independent device to capture CTCs using standard cytomorphological criteria provides the potential of a diagnostic blood test for lung cancer.
Entities:
Keywords:
Circulating tumour cells (CTCs); ClearBridge; lung cancer
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