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

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

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

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Patients with 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 Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Wenhua of Liang
      • Contact: Wenhua o Liang, Ph.D; Phone Number: 00862083062114 00862083062114; Email: liangwh1987@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The pathologically diagnosed patients with non-small cell lung cancer who were performed with NGS technology

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NSCLC patients with driver genes; NSCLC patients and driver genes	Other: Patients with driver genes; Patients with driver genes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in overall survival rates	Differences in overall survival rates of the NSCLC patients with various gene types	2018-2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Statuses of clinical treatment regimens	Statuses of clinical treatment regimens of the NSCLC patients	2018-2022
Relevance of gene types	Relevance of gene types and clinical characteristics of the NSCLC patients	2018-2022
Relevance of overall survival rates and gene types	Relevance of overall survival rates and gene types of the NSCLC patients	2018-2022
Impacts of disease-free survivals on gene types	Impacts of disease-free survivals on gene types of the NSCLC patients	2018-2022
Impacts of progression-free survivals	Impacts of progression-free survivals on gene types of the NSCLC patients	2018-2022
Impact factors of overall survivals	Impact factors of overall survivals of the NSCLC patients	2018-2022

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Wenhua Liang, Ph.D, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer, gene mutations
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: GZH-Gene

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No