Clinical trial NCT03429192: A Study to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Chinese, real-world evidences, NSCLC, lymph skip metastases
Lead sponsor: Tianjin Chest Hospital
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-02-12
Enrollment: 2653
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathologically diagnosed Chinese NSCLC patients with chest surgeries and lymphadenectomy

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in overall survival (OS)
timeFrame: 2014 - 2017
Secondary outcomes:
measure: Percentage of N2 patients with lymph skip metastases
timeFrame: 2014 - 2017
Other outcomes:
measure: Difference in overall survival (OS) (in the subgroups of patients)
timeFrame: 2014 - 2017
measure: Hazard factors of overall survival
timeFrame: 2014 - 2017
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: China People's Liberation Army Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huaxi Technology University
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Tangdu Hospital
state: Shanghai
city: Chengdu
country: China
facility: Huaxi Hospital Affiliate to Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: First Hospital Affiliated to Zhejiang University
state: Zhejiang
Study officials:
affiliation: Tianjin Chest Hospital
name: Xun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.