title: An assessment of diagnostic performance of a filter-based antibody-independent peripheral blood circulating tumour cell capture paired with cytomorphologic criteria for the diagnosis of cancer.
abstract: OBJECTIVE
  Circulating tumour cells (CTCs) are reported to be predictive for prognosis and response to treatment in advanced lung cancer. However, the clinical utility of the CTCs detection remains unknown for early stage lung cancer as the number of CTCs is reported as low, providing challenges in identification. We have evaluated diagnostic performance of filtration-based technology using cytomorphologic criteria in patients undergoing surgery for lung cancer.
  
  
  METHODS
  We processed blood from 76 patients undergoing surgery for known or suspected lung cancer using ScreenCell(®) Cyto filter devices. Captured cells were stained using haematoxylin and eosin and independently assessed by two pathologists for the presence of atypical cells suspicious for cancer. Diagnostic performance was evaluated against pathologist reported diagnoses of cancer from surgically obtained specimens.
  
  
  RESULTS
  Cancer was diagnosed in 57 patients (77.0%), including 32 with primary lung cancer (56.1%). The proportion of patients with early stage primary lung cancer in which CTCs were identified was 18 and 21 (56.3% and 65.6%, respectively) as reported by two pathologists. The agreement between the pathologists was 77.0% corresponding to a kappa-statistic of 53.7% indicating moderate agreement. No significant differences were found for the percentage of CTCs for primary and metastatic cancer as well as for cancer stages. On sensitivity weighted analysis, a sensitivity and specificity were 71.9% (95% CI 60.5-83.0) and 52.9% (95% CI 31.1-77.0), respectively. On specificity weighted analysis, a sensitivity and specificity were 50.9% (95% CI 39.3-64.4) and 82.4% (60.4-96.2), respectively.
  
  
  CONCLUSIONS
  The performance of the tested filter-based antibody-independent technology to capture CTCs using standard cytomorphologic criteria provides the potential of a diagnostic blood test for lung cancer.
authors.affiliation: Royal Brompton and Harefield NHS Foundation Trust, London, UK; National Heart and Lung Institute, Imperial College London, London, UK.
authors.forename: Maxim B
authors.initials: MB
authors.lastname: Freidin
authors.affiliation: Royal Brompton and Harefield NHS Foundation Trust, London, UK; National Heart and Lung Institute, Imperial College London, London, UK.
authors.forename: Andee
authors.initials: A
authors.lastname: Tay
authors.affiliation: Royal Brompton and Harefield NHS Foundation Trust, London, UK; National Heart and Lung Institute, Imperial College London, London, UK.
authors.forename: Dasha V
authors.initials: DV
authors.lastname: Freydina
authors.affiliation: Royal Brompton and Harefield NHS Foundation Trust, London, UK.
authors.forename: Dimple
authors.initials: D
authors.lastname: Chudasama
authors.affiliation: Royal Brompton and Harefield NHS Foundation Trust, London, UK; National Heart and Lung Institute, Imperial College London, London, UK.
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Nicholson
authors.affiliation: Royal Brompton and Harefield NHS Foundation Trust, London, UK.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Rice
authors.affiliation: Royal Brompton and Harefield NHS Foundation Trust, London, UK.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Anikin
authors.affiliation: Royal Brompton and Harefield NHS Foundation Trust, London, UK; National Heart and Lung Institute, Imperial College London, London, UK. Electronic address: e.lim@rbht.nhs.uk.
authors.forename: Eric
authors.initials: E
authors.lastname: Lim
mesh_terms: D000368:Aged; D003581:Cytodiagnosis; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009360:Neoplastic Cells, Circulating / Q000473:pathology*; D011379:Prognosis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
keywords: Circulating tumour cells; Early diagnostics; Lung cancer