Clinical trial NCT03413956: An Observational Study to Explore Clinical Characteristics of the Patients With T1 Non-small Cell Lung Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Chinese
T1 non-small cell lung cancer
Lymph metastases
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 10885
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of the patients with lymph metastases
timeFrame: 2015 - 2017
Secondary outcomes:
measure: Percentages of N0/N1/N2/N3 patients
timeFrame: 2015 - 2017
Other outcomes:
measure: Percentage of N2 patients with lymph nodes
timeFrame: 2015 - 2017
measure: Percentage of patients with lymph metastases categorised by tumor baseline characteristics
timeFrame: 2015 - 2017
measure: Number of lymph nodes in N2 patients
timeFrame: 2015 - 2017
measure: Percentage of patients with N2 skip metastases
timeFrame: 2015 - 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: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College, Huaxi Technology University
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Cancer Institute and Hospital
state: Jiangsu
city: Xi'an
country: China
facility: Xi'an Tangdu Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Hangzhou
country: China
facility: First Hospital Affiliated to Medical College, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Jiangsu Cancer Institute and Hospital
name: Lin Xu
role: PRINCIPAL_INVESTIGATOR
References: