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A Study to Evaluate Effectiveness of Sublobar Dissection in 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: NCT03427567
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
LinkDoc Technology (Beijing) Co. Ltd.
Information provided by (Responsible Party):
XiangNing Fu, Tongji Hospital

Study Description
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Brief Summary:
A study to evaluate effectiveness of sublobar dissection in patients with non-small cell lung cancer

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

Detailed Description:
This is a multi-centre real-world non-interventional observational study. The study data on patient demographic/tumor biological characteristics and clinical treatments were retrospectively collected to evaluate effectiveness of sublobar dissection in the Chinese patients with non-small cell lung cancer who received sublobar dissection.
Study Design
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Study Type : Observational
Actual Enrollment : 3902 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multi-centre Real-world Non-interventional Observational Study to Evaluate Effectiveness of Sublobar Dissection in the Chinese Patients With Non-small Cell Lung Cancer
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : December 1, 2017
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
Sublobar dissection
Chinese NSCLC patients who received sublobar dissection
 Procedure: Sublobar dissection
Sublobar dissection plus lymphadenectomy
Other Name: Surgeries


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2014 - 2017 ]
    Overall survival


Secondary Outcome Measures :
  1. Overall survivals in subgroups [ Time Frame: 2014 - 2017 ]
    Overall survivals categorised by tumor biological characteristics


Other Outcome Measures:
  1. Impact factors of overall survival [ Time Frame: 2014 - 2017 ]
    Impact factors of overall survival as measured by patient demographic/tumor biological characteristics and clinical treatments

  2. Death rates after surgeries [ Time Frame: 2014 - 2017 ]
    Death rates after surgeries

  3. Impact factors of death rates after surgeries [ Time Frame: 2014 - 2017 ]
    Impact factors of death rates after surgeries

  4. Incidence of complications after surgeries [ Time Frame: 2014 - 2017 ]
    Incidence of complications after surgeries


Eligibility Criteria
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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
Chinese patients with pathological diagnosed non-small cell lung cancer who received sublobar dissection and lymphadenectomy
Criteria

Inclusion Criteria:

  • Patients >= 18 years old;
  • Patients who received sublobar dissection from 2014 to 2017 (segment dissection/wedge dissection/segment and wedge dissections);
  • Patients who received selective or systematic lymphadenectomy;
  • Pathologically diagnosed patients with non-small cell lung cancer;
  • Pathological staging: I, II

Exclusion Criteria:

  • Patients who received cancer treatments before surgeries (adjuvant therapies including chemotherapies, radiotherapies, target therapies);
  • Patients who received late-phase or intolerant palliative lobectomy or compromise sublobar dissection;
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): NCT03427567


Locations
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China, Beijing
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
China PLA General Hospital
Beijing, Beijing, China, 100853
China, Henan
Henan cancer hospital
Zhengzhou, Henan, China, 450003
China, Hubei
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, China, 430030
China, Jiangsu
Jiangsu cancer hospital
Nanjing, Jiangsu, China, 210009
China, Shaanxi
Xi'an Tangdu Hospital
Xi'an, Shaanxi, China, 710000
China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China, 200030
China, Sichuan
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, China, 610041
China, Tianjin
Tianjin Chest Hospital
Tianjin, Tianjin, China, 300051
China, Zhejiang
First Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Tongji Hospital
LinkDoc Technology (Beijing) Co. Ltd.
Investigators
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Principal Investigator: Xiangning Fu, PhD Tongji Hospital Affiliated to Tongji Medical College Huazhong Technology University
More Information
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Responsible Party: XiangNing Fu, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03427567    
Other Study ID Numbers: TJ-LC-01
First Posted: February 9, 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 XiangNing Fu, Tongji Hospital:
Chinese
real-world evidences
NSCLC
sublobar dissection
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