A Real-world Study to Explore Recurrence/Metastases of the NSCLC Patients and the Impact Factors of Patient Survivals

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Real-world Study to Explore Recurrence/Metastases of the Early-stage (I-IIIA) NSCLC Patients and the Impact Factors of Patient Survivals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03710616
• Other study ID #: GZH-001
• Status: Recruiting
• Start date: March 24, 2018
• Est. completion date: January 1, 2023

Study information

• Verified date: July 2019
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Jianxing HE, MD
• Phone: 0086-20-83062114
• Email: hejx[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The real-world study was designed to explore recurrence/metastases of the patients with non-small cell lung cancer as measured by patient survivals and the impact factors of patient survivals.

Description:

The trial was designed as a real-world observational study to recruit those patients with pathologically diagnosed early-phase non-small cell lung cancer (NSCLC) who were enrolled in the clinical form 2009 to 2017 and explore recurrence/metastases of the NSCLC patients as measured by patient survivals and the impact factors of patient survivals. The study data on patient demographic characteristics, tumor biological characteristics, and clinicla treatments were collected via a retrospectively review method for evaluation of patient survivals and the relevance of clinical characteristics of the patients and patient survivals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

The patients who meet all the following inclusion criteria will be included in the study:

• The patients who were operated with radical operations of the lung cancer;

• The patients with clinical I-IIIA staging tumors;

• The pathologically diagnosed NSCLC patients;

Exclusion Criteria:

• Not be specified;

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Surgeries
Surgical operations plus systematic lymphadenectomies

Locations

Country	Name	City	State
China	Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact factors of disease-free survival rates	Impact factors of disease-free survival rates	2009-2017
Other	Overall rates	Overall rates within 3 month-, 6 month-, 1 year-, 2 year-, and 3 year- observation periods	2009-2017
Other	Rates of perioperative complications	Rates of perioperative complications	2009-2017
Primary	Disease-free survival rates within the configured observation periods	Disease-free survival rates within 3-month, 6-month, 1-year, 2-year, and 3-year observation periods;	2009-2017
Secondary	Disease-free survival rates at the configured locations and observation periods	Disease-free survival rates at the metastasized lymph nodes, bone, and brain within 3-month, 6-month, 1-year, 2-year, and 3-year observation periods;	2009-2017