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Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma (CTCs detection)

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ClinicalTrials.gov Identifier: NCT02951897
Recruitment Status : Unknown
Verified October 2016 by Deng Bo, MD, Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : November 1, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Deng Bo, MD, Third Military Medical University

Tracking Information
First Submitted Date  ICMJE October 25, 2016
First Posted Date  ICMJE November 1, 2016
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma
Official Title  ICMJE Application of Detecting Circulating Tumor Cells in the Accurate Diagnosis and Treatment of Early Stage Lung Adenocarcinoma
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Adenocarcinoma, Stage I
  • Diagnoses Diseases
  • Circulating Tumor Cells
  • Treatment
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 30, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • stage I lung adenocarcinoma

Exclusion Criteria:

  • cases with any new adjuvant treatment prior to surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02951897
Other Study ID Numbers  ICMJE TMMU-DP-2016-4-25
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deng Bo, MD, Third Military Medical University
Study Sponsor  ICMJE Third Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Third Military Medical University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP