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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429192
• Other study ID #: TJ-N2LC-01
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: May 2018
• Source: Tianjin Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2653
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• Surgery
Surgeries plus dissection of lymph nodes

Locations

Country	Name	City	State
China	China People's Liberation Army Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Huaxi Hospital Affiliate to Sichuan University	Chengdu	Sichuan
China	First Hospital Affiliated to Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Tongji Hospital Affiliated to Huaxi Technology University	Wuhan	Hubei
China	Xi'an Tangdu Hospital	Xi'an	Shanghai
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Chest Hospital	LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Hazard factors of overall survival	Hazard factors of overall survival	2014 - 2017
Primary	Difference in overall survival (OS)	OS difference in the subgroups of N2 patients with lymph skip metastases and non-skip metastases	2014 - 2017
Secondary	Percentage of N2 patients with lymph skip metastases	Percentage of N2 patients with lymph skip metastases	2014 - 2017