An Observational Study to Explore Clinical Characteristics of the Patients With T1 Non-small Cell Lung Cancer

A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of the Chinese Patients With T1 Non-small Cell Lung Cancer Complicated With Lymph Metastases

The real-world observational study was designed to explore the odd factors of lymph metastases in the patients with T1 non-small cell lung cancer, the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Procedure: Surgeries

Detailed Description

The trial is a multi-centre, real-world non-interventional observational study. In the study, the patients with T1 non-small cell lung cancer enrolled in clinics from 2015 to 2017 were included via a retrospectively review method and the study data on patient demographic/tumor biological characteristics, and clinical treatments were collected to explore the clinical odd factors of lymph metastases, evaluate the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

• Study Type: Observational
• Enrollment (Actual): 10885

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
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Tongji Medical College, Huaxi Technology University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Institute and Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Xi'an Tangdu Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • First Hospital Affiliated to Medical College, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The eligible subjects are the Chinese T1 patients with non-small cell lung cancer complicated with lymph metastases

Description

Inclusion Criteria:

• Patients who received surgeries from 2015 to 2017;
• Pathologically diagnosed patients with T1 non-small cell lung cancer;

Exclusion Criteria:

- Patients with tumor treatments (including chemotherapies, radiotherapies, biological therapies, intervention therapies)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NSCLC patients with lymph metastases; Pathologically diagnosed patients with T1 non-small cell lung cancer complicated with lymph metastases after surgeries	Procedure: Surgeries; Surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of the patients with lymph metastases	Percentages of the patients with lymph metastases categorised by patient demographic and tumor biological characteristics	2015 - 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of N0/N1/N2/N3 patients	Percentages of N0/N1/N2/N3 patients in the target population	2015 - 2017

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of N2 patients with lymph nodes	Percentages of N2 patients with lymph nodes in N2 population	2015 - 2017
Percentage of patients with lymph metastases categorised by tumor baseline characteristics	Percentage of patients with lymph metastases categorised by tumor baseline characteristics	2015 - 2017
Number of lymph nodes in N2 patients	Number of lymph nodes in N2 patients categorised by tumor baseline characteristics	2015 - 2017
Percentage of patients with N2 skip metastases	Percentage of patients with N2 skip metastases categorised by tumor baseline characteristics	2015 - 2017

Collaborators and Investigators

• Sponsor: Jiangsu Cancer Institute & Hospital
• Investigators: Principal Investigator: Lin Xu, Jiangsu Cancer Institute and Hospital

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: January 15, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 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; T1 non-small cell lung cancer; Lymph 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: JS-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