A Study to Explore Treatment Regimens and Clinical Outcomes of the NSCLC Patients With Different Dirver Genes

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Prospective Observational Study to Explore Treatment Regimens and Clinical Outcomes of the NSCLC Patients With Different Driver Genes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03710629
• Other study ID #: GZH-Gene
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2018
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Jianxing HE, MD
• Phone: 00862083062114
• Email: hejx[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A single-center, non-interventional prospective observational study in the NSCLC patients with different driver genes

Description:

The trial was designed as a single-center non-interventional prospective observational study to explore clinical treatments of the NSCLC patients with different driver genes, the impact factors of patient survivals, and the relevance of gene types, clinical treatments, and distribution of gene types. The follow-up visits, interactions between the investigators and patients, patient questionnaires/quality of life, and other patient information will be uploaded via mobile APP, and webchat every three months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patients with lung cancer who were performed with next-generation sequencing (NGS) technology from 2015 to 2017;

• The patients who were at least 18 years;

• The pathologically diagnosed patients with non-small cell lung cancer (NSCLC)

Exclusion Criteria:

Related Conditions & MeSH terms

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

Intervention

Other:
• Patients with driver genes
Patients with driver genes

Locations

Country	Name	City	State
China	Wenhua of Liang	Guangzhou	Guangdong

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
Primary	Differences in overall survival rates	Differences in overall survival rates of the NSCLC patients with various gene types	2018-2022
Secondary	Interaction impact between gene types and treatment modalities or regimens on disease-free survivals	Interaction impact between gene types and treatment modalities or regimens on disease-free survivals	2018-2022
Secondary	Statuses of clinical treatment regimens	Statuses of clinical treatment regimens of the NSCLC patients	2018-2022
Secondary	Relevance of gene types	Relevance of gene types and clinical characteristics of the NSCLC patients	2018-2022
Secondary	Relevance of overall survival rates and gene types	Relevance of overall survival rates and gene types of the NSCLC patients	2018-2022
Secondary	Impacts of disease-free survivals on gene types	Impacts of disease-free survivals on gene types of the NSCLC patients	2018-2022
Secondary	Impacts of progression-free survivals	Impacts of progression-free survivals on gene types of the NSCLC patients	2018-2022
Secondary	Impact factors of overall survivals	Impact factors of overall survivals of the NSCLC patients	2018-2022