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A Study to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03429192
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
LinkDoc Technology (Beijing) Co. Ltd.
Information provided by (Responsible Party):
Lingyu Huang, Tianjin Chest Hospital

Study Description
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Brief Summary:
A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Procedure: Surgery

Detailed Description:
A multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases.
Study Design
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Study Type : Observational
Actual Enrollment : 2653 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of Lymph Skip Metastases and Prognoses of N2 Patients With Non-small Cell Lung Cancer
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
N2 non-small cell lung cancer
Chinese patients with N2 non-small cell lung cancer
 Procedure: Surgery
Surgeries plus dissection of lymph nodes


Outcome Measures
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Primary Outcome Measures :
  1. Difference in overall survival (OS) [ Time Frame: 2014 - 2017 ]
    OS difference in the subgroups of N2 patients with lymph skip metastases and non-skip metastases


Secondary Outcome Measures :
  1. Percentage of N2 patients with lymph skip metastases [ Time Frame: 2014 - 2017 ]
    Percentage of N2 patients with lymph skip metastases


Other Outcome Measures:
  1. Difference in overall survival (OS) (in the subgroups of patients) [ Time Frame: 2014 - 2017 ]
    OS difference in subgroups of patients with lymph skip metastases and non-skip metastases categorised by baseline characteristics

  2. Hazard factors of overall survival [ Time Frame: 2014 - 2017 ]
    Hazard factors of overall survival


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pathologically diagnosed Chinese NSCLC patients with chest surgeries and lymphadenectomy
Criteria

Inclusion Criteria:

  • Patients with surgeries from 2014 to 2017;
  • Pathologically diagnosed patients with non-small cell lung cancer;
  • Age > 18 years old;
  • Patients with chest surgeries before hospitalization;
  • Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes);

Exclusion Criteria:

- Patients with radiotherapies, chemotherapies and biological therapies for tumors

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429192


Locations
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China, Beijing
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
China People's Liberation Army Hospital
Beijing, Beijing, China, 100853
China, Henan
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
China, Hubei
Tongji Hospital Affiliated to Huaxi Technology University
Wuhan, Hubei, China, 430030
China, Jiangsu
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China, 200030
Xi'an Tangdu Hospital
Xi'an, Shanghai, China, 710000
China, Sichuan
Huaxi Hospital Affiliate to Sichuan University
Chengdu, Sichuan, China, 610041
China, Zhejiang
First Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Tianjin Chest Hospital
LinkDoc Technology (Beijing) Co. Ltd.
Investigators
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Principal Investigator: Xun Zhang, PhD Tianjin Chest Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lingyu Huang, Professor, Tianjin Chest Hospital
ClinicalTrials.gov Identifier: NCT03429192    
Other Study ID Numbers: TJ-N2LC-01
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lingyu Huang, Tianjin Chest Hospital:
Chinese, real-world evidences, NSCLC, lymph skip metastases
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms