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Comparison of CellSearch and Circulating Tumor Cells (CTC)-Biopsy Systems in Detecting Peripheral Blood Circulating Tumor Cells in Patients with Gastric Cancer.

Author(s): Ning D, Cui K, Liu M, Ou Y, Wang Z, Zou B, Shen Y, Lu X, Li S, Li P

Publication: Med Sci Monit, 2021, Vol. 27, Page e926565

PubMed ID: 33408319 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   This study compared CTC and CTM detection rates between the CTC-Biopsy System and the CellSearch System in peripheral blood from gastric cancer patients. Correlations between detection of CTCs and various clinicopathological factors were also examined. Peripheral blood specimens were collected into CellSave tubes (7.5 mL) and EDTA tubes (5 mL) from 59 gastric cancer patients (mean age=57 y, 49 males, 10 females) and 22 healthy volunteers (controls). CTCs in CellSave tubes were analyzed within 96 h of collection by two technicians using the CellSearch System and defined as round or oval epithelial cells expressing cell surface antigen epithelial cell adhesion molecule (EpCAM), cytokeratin (CK), and DAPI (4’,6-2-amino-2-benzene indole) without CD45 expression (EpCAM+/CK+/DAPI+/CD45-). CTCs were isolated from EDTA blood using the CTC-Biopsy System within 24 h of collection. Filter membranes were adhered to slides, analyzed independently by two cytopathologists, and cells that met ≥4 established criteria were considered CTCs (atypical nuclei, >0.8 ratio of nucleus to cytoplasm, cell diameter >15 μm, dark and uneven staining of the nucleus, thickened nuclear membrane with depressions and/or folds, nuclear deviation). Specimens were considered positive if one or more CTCs were detected and groups of three or more cells were considered a CTM.

   Summary of Findings:

   The CTC detection rate was significantly higher using the CTC-Biopsy System than the CellSearch (47.46% versus 27.12%, κ=0.179, P<0.001) and while CTMs were detected with the CTC-Biopsy System in 15 patients (25.42%), none were detected using the CellSearch System. A significant association was found between detection of CTCs with the CellSearch System and neutrophil count, lymphocyte count, neutrophil/lymphocyte ratio, serum CA199, distant metastasis, clinical stage, lymph node metastasis, tumor location, tumor size, extent of vascular invasion, and clinical stage of cancer (P<0.05, all). Detection of CTCs with the CTC-Biopsy System was not associated with clinicopathological factors except with neutrophil/lymphocyte ratio and serum CA199 in patients with Stage I/II cancer and with the degree of tumor differentiation in Stage III/IV patients (P<0.05, all). There was no significant correlation between CTM detection with the CTC-Biopsy System and clinicopathological factors with the exception of serum CEA levels in patients with Stage I/II cancer and degree of tumor differentiation in Stage III/IV patients (P<0.05, both). No CTCs or CTMs were detected in blood from normal controls using either detection system.

   Biospecimens

   • Bodily Fluid - Blood

   Preservative Types

   • Other Preservative
   • None (Fresh)

   Diagnoses:

   • Neoplastic - Carcinoma
   • Normal

   Platform:

   Analyte	Technology Platform
   Cell count/volume	Light microscopy
   Cell count/volume	Fluorescent microscopy

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Preaquisition	Patient age	<60 y ≥60 y
   Preaquisition	Patient gender	Female Male
   Biospecimen Aliquots and Components	Cell capture method	CTC-Biopsy System CellSearch System
   Preaquisition	Biomarker level	Serum CA199 Serum CEA
   Preaquisition	Diagnosis/ patient condition	Clinical stage (I/II, II/IV) Tumor size (<5 cm, ≥5 cm) Tumor location (upper third, middle third, lower third) Presence/absence of vascular invasion Degree of tumor differentiation (low, low medium, medium, high) Lymph node metastasis present/absent Lymphocyte counts Platelet counts Neutrophil/lymphocyte ratio

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