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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03724500
Other study ID # CGMH-IRB-104-8753B
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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 remain 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. 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.


Description:

Lung cancer was a major cause of cancer-related death worldwide. According to statistical data from Ministry of Health and Welfare, the incidence of lung cancer related death was 25.5 per 100,000 population. According to NCCN guideline, the standard treatment for patients with resectable disease is anatomic resection and mediastinal lymph node dissection. The current prognostic system, TNM system, was based of patho-histologic characteristics and this system provide the most important information about disease-free and overall survival for corresponding disease severity. According to investigators previous studies, investigators've identified risk factors for all lung cancer patients with resectable disease and poor prognostic factors in different TNM stage. Investigators could utilized factors that designed for all patients as an initial survey and further subgroup patients into high or low risk for relapse in subsequent stratification that utilized grading system in different TMN stage. If investigators could identified high risk patients, more aggressive treatment and follow up program may decreased risk of disease relapse and prolong patient survival. 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 remain 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 65
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Non-small cell lung cancer patients with stage I to III 2. Patients with resectable suspicious pulmonary malignant lesion 1. no pre-operation diagnosis ( patients refused biopsy or difficult for biopsy) 2. image survey showed clinical stage I to III Exclusion Criteria: 1. Final pathology coexisted with small cell lung cancer component 2. Patients who presented as stage IIIb or IV. 3. Not received curative intended surgery due to multi-comorbidities. 4. Patients who presented in tumor seeding or positive resection in the final pathology 5. Patients who received neoadjuvant therapy.

Study Design


Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Khoury S, Tran N. Circulating microRNAs: potential biomarkers for common malignancies. Biomark Med. 2015;9(2):131-51. doi: 10.2217/bmm.14.102. — View Citation

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. — View Citation

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. — View Citation

O'Flaherty JD, Gray S, Richard D, Fennell D, O'Leary JJ, Blackhall FH, O'Byrne KJ. Circulating tumour cells, their role in metastasis and their clinical utility in lung cancer. Lung Cancer. 2012 Apr;76(1):19-25. doi: 10.1016/j.lungcan.2011.10.018. Epub 2011 Dec 29. — View Citation

Pantel K, Speicher MR. The biology of circulating tumor cells. Oncogene. 2016 Mar 10;35(10):1216-24. doi: 10.1038/onc.2015.192. Epub 2015 Jun 8. — View Citation

Sawabata N, Okumura M, Utsumi T, Inoue M, Shiono H, Minami M, Nishida T, Sawa Y. Circulating tumor cells in peripheral blood caused by surgical manipulation of non-small-cell lung cancer: pilot study using an immunocytology method. Gen Thorac Cardiovasc Surg. 2007 May;55(5):189-92. doi: 10.1007/s11748-007-0101-2. — View Citation

Sheu CC, Yu YP, Tsai JR, Chang MY, Lin SR, Hwang JJ, Chong IW. Development of a membrane array-based multimarker assay for detection of circulating cancer cells in patients with non-small cell lung cancer. Int J Cancer. 2006 Sep 15;119(6):1419-26. doi: 10.1002/ijc.21999. — View Citation

Tanaka F, Yoneda K, Kondo N, Hashimoto M, Takuwa T, Matsumoto S, Okumura Y, Rahman S, Tsubota N, Tsujimura T, Kuribayashi K, Fukuoka K, Nakano T, Hasegawa S. Circulating tumor cell as a diagnostic marker in primary lung cancer. Clin Cancer Res. 2009 Nov 15;15(22):6980-6. doi: 10.1158/1078-0432.CCR-09-1095. Epub 2009 Nov 3. — View Citation

Tognela A, Spring KJ, Becker T, Caixeiro NJ, Bray VJ, Yip PY, Chua W, Lim SH, de Souza P. Predictive and prognostic value of circulating tumor cell detection in lung cancer: a clinician's perspective. Crit Rev Oncol Hematol. 2015 Feb;93(2):90-102. doi: 10.1016/j.critrevonc.2014.10.001. Epub 2014 Oct 12. — View Citation

Vaz AP, Fernandes G, Souto Moura C, Bastos P, Queiroga H, Hespanhol V. Integrated PET/CT in non small cell lung cancer staging--clinical and pathological agreement. Rev Port Pneumol. 2012 May-Jun;18(3):109-14. doi: 10.1016/j.rppneu.2012.01.004. Epub 2012 Mar 8. English, Portuguese. — View Citation

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. — View Citation

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. Erratum In: Medicine (Baltimore). 2015 Sep;94(39):1. — View Citation

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. Erratum In: Medicine (Baltimore). 2016 Jan;95(2):e65b7. Medicine (Baltimore). 2016 Jan 15;95(2):e65b7. — View Citation

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. — View Citation

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. Erratum In: Medicine (Baltimore). 2015 Oct;94(43):1. — View Citation

Yoon SO, Kim YT, Jung KC, Jeon YK, Kim BH, Kim CW. TTF-1 mRNA-positive circulating tumor cells in the peripheral blood predict poor prognosis in surgically resected non-small cell lung cancer patients. Lung Cancer. 2011 Feb;71(2):209-16. doi: 10.1016/j.lungcan.2010.04.017. Epub 2010 May 14. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Secondary Malignancy prediction capacity of circulating tumor cell counts Relationship between pre-operation circulating tumor cell counts and malignancy Pre-operation circulating tumor cells ( sampled before operation at operation day)
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