Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma
NCT ID: NCT02951897
Last Updated: 2016-11-02
Study Results
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Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2016-04-30
2019-12-31
Brief Summary
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Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far, CTCs-detection technologies can be divided into epithelial cell adhesion molecule (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung Adenocarcinoma cases.
The investigator aim to explore whether CTCs detection prior to surgery can be contributive to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy of early stage lung Adenocarcinoma.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IA-CTC-High-enhance
IA lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
lobectomy
chemotherapy（pemetrexed+CISPLATIN）
Lymphadenectomy
Lymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed.
CanPatrolTM to detect CTCs
CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs.
IA-CTC-High-controls
IA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
lobectomy
Lymphadenectomy
Lymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed.
CanPatrolTM to detect CTCs
CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs.
IA-CTC-low-controls
IA lung adenocarcinoma cases with low abundant CTCs prior to operation will only undergo segmentectomy. Postoperative CTC monitoring will be conducted.
segmentecomy
CanPatrolTM to detect CTCs
CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs.
IB-CTC-High-enhance
IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
lobectomy
chemotherapy（pemetrexed+CISPLATIN）
Lymphadenectomy
Lymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed.
CanPatrolTM to detect CTCs
CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs.
IB-CTC-High-controls
IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
lobectomy
Lymphadenectomy
Lymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed.
CanPatrolTM to detect CTCs
CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs.
IB-CTC-low-controls
IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.
lobectomy
Lymphadenectomy
Lymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed.
CanPatrolTM to detect CTCs
CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs.
Interventions
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lobectomy
segmentecomy
chemotherapy（pemetrexed+CISPLATIN）
Lymphadenectomy
Lymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed.
CanPatrolTM to detect CTCs
CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
45 Years
70 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Deng Bo, MD
Principal Investigator
Locations
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Daping hospital
Chongqing, , China
Countries
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Facility Contacts
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Bo Deng
Role: primary
References
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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.
Bayarri-Lara C, Ortega FG, Cueto Ladron de Guevara A, Puche JL, Ruiz Zafra J, de Miguel-Perez D, Ramos AS, Giraldo-Ospina CF, Navajas Gomez JA, Delgado-Rodriguez M, Lorente JA, Serrano MJ. Circulating Tumor Cells Identify Early Recurrence in Patients with Non-Small Cell Lung Cancer Undergoing Radical Resection. PLoS One. 2016 Feb 25;11(2):e0148659. doi: 10.1371/journal.pone.0148659. eCollection 2016.
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.
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.
Liu L, Liao GQ, He P, Zhu H, Liu PH, Qu YM, Song XM, Xu QW, Gao Q, Zhang Y, Chen WF, Yin YH. Detection of circulating cancer cells in lung cancer patients with a panel of marker genes. Biochem Biophys Res Commun. 2008 Aug 8;372(4):756-60. doi: 10.1016/j.bbrc.2008.05.101. Epub 2008 Jun 2.
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Nair VS, Keu KV, Luttgen MS, Kolatkar A, Vasanawala M, Kuschner W, Bethel K, Iagaru AH, Hoh C, Shrager JB, Loo BW Jr, Bazhenova L, Nieva J, Gambhir SS, Kuhn P. An observational study of circulating tumor cells and (18)F-FDG PET uptake in patients with treatment-naive non-small cell lung cancer. PLoS One. 2013 Jul 5;8(7):e67733. doi: 10.1371/journal.pone.0067733. Print 2013.
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.
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Yie SM, Lou B, Ye SR, He X, Cao M, Xie K, Ye NY, Lin R, Wu SM, Xiao HB, Gao E. Clinical significance of detecting survivin-expressing circulating cancer cells in patients with non-small cell lung cancer. Lung Cancer. 2009 Feb;63(2):284-90. doi: 10.1016/j.lungcan.2008.05.024. Epub 2008 Jul 7.
Funaki S, Sawabata N, Nakagiri T, Shintani Y, Inoue M, Kadota Y, Minami M, Okumura M. Novel approach for detection of isolated tumor cells in pulmonary vein using negative selection method: morphological classification and clinical implications. Eur J Cardiothorac Surg. 2011 Aug;40(2):322-7. doi: 10.1016/j.ejcts.2010.11.029. Epub 2011 Jan 7.
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Other Identifiers
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TMMU-DP-2016-4-25
Identifier Type: -
Identifier Source: org_study_id