NCT03721133|UnknownDMC
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Sponsor study identifier
observational
150
1 country
1
Study Start
December 4, 2018
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
From literature review, circulating tumor cell was demonstrated its possible role in disease relapse. It was rare nit could be identified in all lung cancer patients. In addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. Therefore, circulating tumor cell could play a role in detect disease relapse and appropriate treatment could be given more earlier and further prolong patients' survival. However, the detail clinical significance of circulating tumor still remains unknown. The aim of this study was evaluate the clinical significance, including present timing, numbers, and correlation to disease relapse, of circulating tumor cell in lung cancer patients. The investigators want to clarify the clinical significance between circulating tumor cell and clinical presentation of lung cancer in order to establish new prediction model and improve lung cancer patients' survival.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2018
Actual (reported)October 26, 2018
Actual (reported)December 4, 2018
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Variation trend of circulating tumor cell counts
Relationship between variation trend of circulating tumor cells and disease relapse in patients with a suspicious pulmonary lesion after tumor resection
1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.need complete 5-years surveillance (disease status confirmation)
Validation of variation trend of circulating tumor cell counts
sequence patient recruitment for validation
1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.model establish model (case 1 to 50) versus validation group ( case 51-120) 3. need complete 5-years surveillance (disease status confirmation)
Patients with a resectable malignant or suspicious malignant pulmonary lesion
Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
Fernandes G, Sucena M, Lombardia E, Machado A, Hespanhol V, Queiroga H. Non small cell lung cancer - comparison between clinical and pathological staging. Rev Port Pneumol. 2006 Jul-Aug;12(4):337-57. English, Portuguese.
McCann J. PET scans approved for detecting metastatic non-small-cell lung cancer. J Natl Cancer Inst. 1998 Jan 21;90(2):94-6. doi: 10.1093/jnci/90.2.94. No abstract available.
Chia-Hsun Hsieh, MD
Chang Gung Memorial Hospital
Yi-Cheng Wu, MD
Chang Gung Memorial Hospital
Cheng-Ta Yang, MD
Chang Gung Memorial Hospital
JUI-YING Fu, MD
Chang Gung Memorial Hospital
First Submitted
October 22, 2018
First Posted
October 26, 2018
Study Start
December 4, 2018
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
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Wu CY, Fu JY, Wu CF, Hsieh MJ, Liu YH, Wu YC, Yang CT, Tsai YH. Survival Prediction Model Using Clinico-Pathologic Characteristics for Nonsmall Cell Lung Cancer Patients After Curative Resection. Medicine (Baltimore). 2015 Nov;94(45):e2013. doi: 10.1097/MD.0000000000002013.
Wu CY, Fu JY, Wu CF, Liu YH, Hsieh MJ, Wu YC, Yang CT, Tsai YH. Pathologic Stage of Nonsmall Cell Lung Cancer Patients Presenting as Resectable Cases After Neoadjuvant Therapy Did Not Predict the Prognosis. Medicine (Baltimore). 2015 Oct;94(40):1. doi: 10.1097/MD.0000000000001700.
Wu CF, Fu JY, Yeh CJ, Liu YH, Hsieh MJ, Wu YC, Wu CY, Tsai YH, Chou WC. Recurrence Risk Factors Analysis for Stage I Non-small Cell Lung Cancer. Medicine (Baltimore). 2015 Aug;94(32):e1337. doi: 10.1097/MD.0000000000001337.
Wu CF, Wu CY, Fu JY, Wang CW, Liu YH, Hsieh MJ, Wu YC. Prognostic value of metastatic N1 lymph node ratio and angiolymphatic invasion in patients with pathologic stage IIA non-small cell lung cancer. Medicine (Baltimore). 2014 Oct;93(20):e102. doi: 10.1097/MD.0000000000000102.
Hsieh CP, Fu JY, Liu YH, Yang CT, Hsieh MJ, Tsai YH, Wu YC, Wu CY. Prognostic factors in resectable pathological N2 disease of non-small cell lung cancer. Biomed J. 2015 Jul-Aug;38(4):329-35. doi: 10.4103/2319-4170.145765.
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Hou JM, Greystoke A, Lancashire L, Cummings J, Ward T, Board R, Amir E, Hughes S, Krebs M, Hughes A, Ranson M, Lorigan P, Dive C, Blackhall FH. Evaluation of circulating tumor cells and serological cell death biomarkers in small cell lung cancer patients undergoing chemotherapy. Am J Pathol. 2009 Aug;175(2):808-16. doi: 10.2353/ajpath.2009.090078. Epub 2009 Jul 23.
Hofman V, Long E, Ilie M, Bonnetaud C, Vignaud JM, Flejou JF, Lantuejoul S, Piaton E, Mourad N, Butori C, Selva E, Marquette CH, Poudenx M, Sibon S, Kelhef S, Venissac N, Jais JP, Mouroux J, Molina TJ, Vielh P, Hofman P. Morphological analysis of circulating tumour cells in patients undergoing surgery for non-small cell lung carcinoma using the isolation by size of epithelial tumour cell (ISET) method. Cytopathology. 2012 Feb;23(1):30-8. doi: 10.1111/j.1365-2303.2010.00835.x. Epub 2011 Jan 6.
Nieva J, Wendel M, Luttgen MS, Marrinucci D, Bazhenova L, Kolatkar A, Santala R, Whittenberger B, Burke J, Torrey M, Bethel K, Kuhn P. High-definition imaging of circulating tumor cells and associated cellular events in non-small cell lung cancer patients: a longitudinal analysis. Phys Biol. 2012 Feb;9(1):016004. doi: 10.1088/1478-3975/9/1/016004. Epub 2012 Feb 3.
Hofman V, Bonnetaud C, Ilie MI, Vielh P, Vignaud JM, Flejou JF, Lantuejoul S, Piaton E, Mourad N, Butori C, Selva E, Poudenx M, Sibon S, Kelhef S, Venissac N, Jais JP, Mouroux J, Molina TJ, Hofman P. Preoperative circulating tumor cell detection using the isolation by size of epithelial tumor cell method for patients with lung cancer is a new prognostic biomarker. Clin Cancer Res. 2011 Feb 15;17(4):827-35. doi: 10.1158/1078-0432.CCR-10-0445. Epub 2010 Nov 23.
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Khoury S, Tran N. Circulating microRNAs: potential biomarkers for common malignancies. Biomark Med. 2015;9(2):131-51. doi: 10.2217/bmm.14.102.
Hofman V, Ilie MI, Long E, Selva E, Bonnetaud C, Molina T, Venissac N, Mouroux J, Vielh P, Hofman P. Detection of circulating tumor cells as a prognostic factor in patients undergoing radical surgery for non-small-cell lung carcinoma: comparison of the efficacy of the CellSearch Assay and the isolation by size of epithelial tumor cell method. Int J Cancer. 2011 Oct 1;129(7):1651-60. doi: 10.1002/ijc.25819. Epub 2011 Mar 11.
Went PT, Lugli A, Meier S, Bundi M, Mirlacher M, Sauter G, Dirnhofer S. Frequent EpCam protein expression in human carcinomas. Hum Pathol. 2004 Jan;35(1):122-8. doi: 10.1016/j.humpath.2003.08.026.
Fu JY, Wen CT, Wu CF, Hsieh JC, Chang PC, Hsieh MJ, Liu YH, Lin YJ, Chang SC, Wu CY. Integrating Pathologic Stage and Perioperative Circulating Tumor Cell Variations: Early Relapse Prediction Model for Resectable Non-Small Cell Lung Cancer. JCO Precis Oncol. 2025 Apr;9:e2400709. doi: 10.1200/PO-24-00709. Epub 2025 Apr 28.
ChingFeng Wu, MD
Chang Gung Memorial Hospital
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 22, 2024
Record last verified: 2024-03
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