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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413956
• Other study ID #: JS-LC-01
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: May 2018
• Source: Jiangsu Cancer Institute & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10885
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Surgeries
Surgeries

Locations

Country	Name	City	State
China	China People's Liberation Army Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	West China Hospital	Chengdu	Sichuan
China	First Hospital Affiliated to Medical College, Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Cancer Institute and Hospital	Nanjing	Jiangsu
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Tongji Hospital Affiliated to Tongji Medical College, Huaxi Technology University	Wuhan	Hubei
China	Xi'an Tangdu Hospital	Xi'an	Shaanxi
China	Henan cancer hospital	Zhengzhou	Henan
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of N2 patients with lymph nodes	Percentages of N2 patients with lymph nodes in N2 population	2015 - 2017
Other	Percentage of patients with lymph metastases categorised by tumor baseline characteristics	Percentage of patients with lymph metastases categorised by tumor baseline characteristics	2015 - 2017
Other	Number of lymph nodes in N2 patients	Number of lymph nodes in N2 patients categorised by tumor baseline characteristics	2015 - 2017
Other	Percentage of patients with N2 skip metastases	Percentage of patients with N2 skip metastases categorised by tumor baseline characteristics	2015 - 2017
Primary	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	Percentages of N0/N1/N2/N3 patients	Percentages of N0/N1/N2/N3 patients in the target population	2015 - 2017