October 25, 2016
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November 1, 2016
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November 2, 2016
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April 2016
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December 2019 (Final data collection date for primary outcome measure)
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Disease free survival [ Time Frame: From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first, assessed up to 60 months ]
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Same as current
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Not Provided
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Not Provided
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Not Provided
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Not Provided
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Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma
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Application of Detecting Circulating Tumor Cells in the Accurate Diagnosis and Treatment of Early Stage Lung Adenocarcinoma
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In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or progression.
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.
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Not Provided
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Interventional
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Not Applicable
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Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
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- Lung Adenocarcinoma, Stage I
- Diagnoses Diseases
- Circulating Tumor Cells
- Treatment
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- Procedure: lobectomy
- Procedure: segmentecomy
- Drug: chemotherapy(pemetrexed+CISPLATIN)
- Procedure: 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.
- Other: 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.
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- Active Comparator: 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.
Interventions:
- Procedure: lobectomy
- Drug: chemotherapy(pemetrexed+CISPLATIN)
- Procedure: Lymphadenectomy
- Other: CanPatrolTM to detect CTCs
- Placebo Comparator: 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.
Interventions:
- Procedure: lobectomy
- Procedure: Lymphadenectomy
- Other: CanPatrolTM to detect CTCs
- Placebo Comparator: 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.
Interventions:
- Procedure: segmentecomy
- Other: CanPatrolTM to detect CTCs
- Active Comparator: 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.
Interventions:
- Procedure: lobectomy
- Drug: chemotherapy(pemetrexed+CISPLATIN)
- Procedure: Lymphadenectomy
- Other: CanPatrolTM to detect CTCs
- Placebo Comparator: 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.
Interventions:
- Procedure: lobectomy
- Procedure: Lymphadenectomy
- Other: CanPatrolTM to detect CTCs
- Placebo Comparator: 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.
Interventions:
- Procedure: lobectomy
- Procedure: Lymphadenectomy
- Other: CanPatrolTM to detect CTCs
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- Hofman V, Bonnetaud C, Ilie MI, Vielh P, Vignaud JM, Fléjou JF, Lantuejoul S, Piaton E, Mourad N, Butori C, Selva E, Poudenx M, Sibon S, Kelhef S, Vénissac 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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- Hofman V, Ilie MI, Long E, Selva E, Bonnetaud C, Molina T, Vénissac 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.
- Yamashita JI, Kurusu Y, Fujino N, Saisyoji T, Ogawa M. Detection of circulating tumor cells in patients with non-small cell lung cancer undergoing lobectomy by video-assisted thoracic surgery: a potential hazard for intraoperative hematogenous tumor cell dissemination. J Thorac Cardiovasc Surg. 2000 May;119(5):899-905.
- 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.
- Chen X, Wang X, He H, Liu Z, Hu JF, Li W. Combination of circulating tumor cells with serum carcinoembryonic antigen enhances clinical prediction of non-small cell lung cancer. PLoS One. 2015 May 21;10(5):e0126276. doi: 10.1371/journal.pone.0126276. eCollection 2015.
- 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.
- Yin J, Wang Y, Yin H, Chen W, Jin G, Ma H, Dai J, Chen J, Jiang Y, Wang H, Liu Z, Hu Z, Shen H. Circulating Tumor Cells Enriched by the Depletion of Leukocytes with Bi-Antibodies in Non-Small Cell Lung Cancer: Potential Clinical Application. PLoS One. 2015 Aug 28;10(8):e0137076. doi: 10.1371/journal.pone.0137076. eCollection 2015.
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Unknown status
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120
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Same as current
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December 2019
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December 2019 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- stage I lung adenocarcinoma
Exclusion Criteria:
- cases with any new adjuvant treatment prior to surgery
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Sexes Eligible for Study: |
All |
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45 Years to 70 Years (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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China
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NCT02951897
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TMMU-DP-2016-4-25
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Yes
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Not Provided
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Deng Bo, MD, Third Military Medical University
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Third Military Medical University
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Not Provided
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Not Provided
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Third Military Medical University
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October 2016
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