A Study to Evaluate Effectiveness of Sublobar Dissection in Patients With Non-small Cell Lung Cancer

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

A study to evaluate effectiveness of sublobar dissection in patients with non-small cell lung cancer

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 3902

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China, 100853
      • China PLA General Hospital
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Huazhong Technology Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Xi'an Tangdu Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Huaxi Hospital Affiliated to Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300051
      • Tianjin Chest Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • First Hospital Affiliated to Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sublobar dissection; Chinese NSCLC patients who received sublobar dissection	Procedure: Sublobar dissection; Sublobar dissection plus lymphadenectomy; Other Names: Surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	2014 - 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survivals in subgroups	Overall survivals categorised by tumor biological characteristics	2014 - 2017

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact factors of overall survival	Impact factors of overall survival as measured by patient demographic/tumor biological characteristics and clinical treatments	2014 - 2017
Death rates after surgeries	Death rates after surgeries	2014 - 2017
Impact factors of death rates after surgeries	Impact factors of death rates after surgeries	2014 - 2017
Incidence of complications after surgeries	Incidence of complications after surgeries	2014 - 2017

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Xiangning Fu, PhD, Tongji Hospital Affiliated to Tongji Medical College Huazhong Technology University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC; Chinese; real-world evidences; sublobar dissection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TJ-LC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No