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

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: Patients with driver genes

• Registration Number: NCT03710629
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-10
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-15
• Last Update Submitted: 2018-10-15
• Study First Posted: 2018-10-18
• Last Update Posted: 2018-10-18
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

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

-None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NSCLC patients with driver genes	Patients with driver genes	NSCLC patients and driver genes

Primary Outcome Measures

Name	Time	Method
Differences in overall survival rates	2018-2022	Differences in overall survival rates of the NSCLC patients with various gene types

Secondary Outcome Measures

Name	Time	Method
Relevance of gene types	2018-2022	Relevance of gene types and clinical characteristics of the NSCLC patients
Interaction impact between gene types and treatment modalities or regimens on disease-free survivals	2018-2022	Interaction impact between gene types and treatment modalities or regimens on disease-free survivals
Impacts of progression-free survivals	2018-2022	Impacts of progression-free survivals on gene types of the NSCLC patients
Statuses of clinical treatment regimens	2018-2022	Statuses of clinical treatment regimens of the NSCLC patients
Impacts of disease-free survivals on gene types	2018-2022	Impacts of disease-free survivals on gene types of the NSCLC patients
Relevance of overall survival rates and gene types	2018-2022	Relevance of overall survival rates and gene types of the NSCLC patients
Impact factors of overall survivals	2018-2022	Impact factors of overall survivals of the NSCLC patients

Trial Locations

Locations (1)

Wenhua of Liang; 🇨🇳 Guangzhou, Guangdong, China