PMID- 29397019 OWN - NLM STAT- MEDLINE DCOM- 20190405 LR - 20210217 IS - 1437-4331 (Electronic) IS - 1434-6621 (Linking) VI - 56 IP - 6 DP - 2018 May 24 TI - Use of circulating tumor cells in prospective clinical trials for NSCLC patients - standardization of the pre-analytical conditions. PG - 980-989 LID - 10.1515/cclm-2017-0764 [doi] AB - BACKGROUND: Circulating tumor cells (CTCs) hold potential for noninvasive diagnosis, prognosis and prediction testing in non-small cell lung cancer (NSCLC) patients. Minimizing degradation or loss of CTCs is pivotal for detection and profiling of the low abundance and fragile CTCs, particularly in clinical trials. We prospectively investigated (NCT02372448) whether a new blood collection device performed better compared to commonly used K3EDTA tubes, when subjected to long-term sample storage. METHODS: Blood samples were drawn into K3EDTA and blood collection tubes (BCT) (Streck), and filtered by the Isolation by SizE of Tumor/Trophoblastic Cells (ISET(R) system), for CTC detection in two study populations of NSCLC patients; the training set of 14 patients with stage II/IV NSCLC, and the validation set of 36 patients with stage IV NSCLC). MET expression was evaluated by immunocytochemistry (ICC) and anaplastic lymphoma kinase (ALK) gene rearrangement by break-apart fluorescence in situ hybridization (FISH) on ISET-enriched CTCs. RESULTS: Blood processed after 24 h and 48 h in BCT tubes showed stable CTCs counts and integrity, whereas CTCs in K3EDTA tubes showed an altered morphology in all patients. CTCs recovered in BCT or K3EDTA tubes at 24 and 48 h were evaluable by ICC for MET expression and by FISH for ALK rearrangement. CONCLUSIONS: The BCT tubes gave a high yield and preserved the integrity of CTCs after 24 and 48 h of storage at room temperature, which facilitate their molecular characterization in NSCLC patients entering clinical trials. FAU - Ilie, Marius AU - Ilie M AUID- ORCID: 0000-0002-2014-1236 AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Laboratory of Clinical and Experimental Pathology and Liquid Biopsy Laboratory, Nice, France. AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Hospital-Integrated Biobank (BB-0033-00025), Nice, France. AD - Universite Cote d'Azur, CHU de Nice, Institute of Research on Cancer and Ageing of Nice (IRCAN), Inserm U1081, CNRS UMR7284, Team 4, Nice, France. FAU - Hofman, Veronique AU - Hofman V AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Laboratory of Clinical and Experimental Pathology and Liquid Biopsy Laboratory, Nice, France. AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Hospital-Integrated Biobank (BB-0033-00025), Nice, France. AD - Universite Cote d'Azur, CHU de Nice, Institute of Research on Cancer and Ageing of Nice (IRCAN), Inserm U1081, CNRS UMR7284, Team 4, Nice, France. FAU - Leroy, Sylvie AU - Leroy S AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Department of Pulmonary Medicine and Oncology, Nice, France. FAU - Cohen, Charlotte AU - Cohen C AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Department of Thoracic Surgery, Nice, France. FAU - Heeke, Simon AU - Heeke S AD - Universite Cote d'Azur, CHU de Nice, Institute of Research on Cancer and Ageing of Nice (IRCAN), Inserm U1081, CNRS UMR7284, Team 4, Nice, France. FAU - Cattet, Florian AU - Cattet F AD - Universite Cote d'Azur, CHU de Nice, Department of Anesthesiology and Critical Care, Nice, France. FAU - Bence, Coraline AU - Bence C AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Laboratory of Clinical and Experimental Pathology and Liquid Biopsy Laboratory, Nice, France. FAU - Lalvee, Salome AU - Lalvee S AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Laboratory of Clinical and Experimental Pathology and Liquid Biopsy Laboratory, Nice, France. FAU - Mouroux, Jerome AU - Mouroux J AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Department of Thoracic Surgery, Nice, France. FAU - Marquette, Charles-Hugo AU - Marquette CH AD - Universite Cote d'Azur, CHU de Nice, Institute of Research on Cancer and Ageing of Nice (IRCAN), Inserm U1081, CNRS UMR7284, Team 4, Nice, France. AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Department of Pulmonary Medicine and Oncology, Nice, France. FAU - Hofman, Paul AU - Hofman P AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Laboratory of Clinical and Experimental Pathology and Liquid Biopsy Laboratory, Nice, France. AD - Universite Cote d'Azur, CHU de Nice, University Hospital Federation OncoAge, Hospital-Integrated Biobank (BB-0033-00025), Nice, France. AD - Universite Cote d'Azur, CHU de Nice, Institute of Research on Cancer and Ageing of Nice (IRCAN), Inserm U1081, CNRS UMR7284, Team 4, Nice, France. CN - STALKLUNG01 and AIR Study Consortium Investigators LA - eng PT - Journal Article PL - Germany TA - Clin Chem Lab Med JT - Clinical chemistry and laboratory medicine JID - 9806306 RN - 9G34HU7RV0 (Edetic Acid) SB - IM MH - Adult MH - Carcinoma, Non-Small-Cell Lung/*blood/genetics MH - Cell-Free System MH - *Clinical Trials as Topic MH - Edetic Acid/chemistry MH - Female MH - Humans MH - In Situ Hybridization, Fluorescence MH - Lung Neoplasms/*blood/genetics MH - Male MH - Middle Aged MH - *Neoplastic Cells, Circulating MH - Prospective Studies OTO - NOTNLM OT - BCT OT - Isolation by SizE of Tumor/Trophoblastic Cells (ISET) OT - K3EDTA OT - circulating tumor cells OT - non-small cell lung cancer (NSCLC) OT - stability EDAT- 2018/02/06 06:00 MHDA- 2019/04/06 06:00 CRDT- 2018/02/04 06:00 PHST- 2017/08/26 00:00 [received] PHST- 2017/12/26 00:00 [accepted] PHST- 2018/02/06 06:00 [pubmed] PHST- 2019/04/06 06:00 [medline] PHST- 2018/02/04 06:00 [entrez] AID - cclm-2017-0764 [pii] AID - 10.1515/cclm-2017-0764 [doi] PST - ppublish SO - Clin Chem Lab Med. 2018 May 24;56(6):980-989. doi: 10.1515/cclm-2017-0764.