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

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

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

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 2653

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China, 100853
      • China People's Liberation Army Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Huaxi Technology University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
    • Xi'an, Shanghai, China, 710000
      • Xi'an Tangdu Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Huaxi Hospital Affiliate to Sichuan University
  • 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

Pathologically diagnosed Chinese NSCLC patients with chest surgeries and lymphadenectomy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in overall survival (OS)	OS difference in the subgroups of N2 patients with lymph skip metastases and non-skip metastases	2014 - 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of N2 patients with lymph skip metastases	Percentage of N2 patients with lymph skip metastases	2014 - 2017

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in overall survival (OS) (in the subgroups of patients)	OS difference in subgroups of patients with lymph skip metastases and non-skip metastases categorised by baseline characteristics	2014 - 2017
Hazard factors of overall survival	Hazard factors of overall survival	2014 - 2017

Collaborators and Investigators

• Sponsor: Tianjin Chest Hospital
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Xun Zhang, PhD, Tianjin Chest Hospital

Publications and helpful links

General Publications

• Li X, Li X, Fu X, Liu L, Liu Y, Zhao H, Li Y, Hu J, Xu L, Liu D, Yang H, Zhang X. Survival benefit of skip metastases in surgically resected N2 non-small cell lung cancer: A multicenter observational study of a large cohort of the Chinese patients. Eur J Surg Oncol. 2020 Oct;46(10 Pt A):1874-1881. doi: 10.1016/j.ejso.2019.12.015. Epub 2019 Dec 18.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (ACTUAL): February 12, 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: Chinese, real-world evidences, NSCLC, lymph skip metastases
• 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-N2LC-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