Analysis of Driver Gene Mutation in Early Stage Non-small Cell Lung Cancer

Molecular Metastasis in Lymph Nodes is Associated With Survival of Patients With Stage I NSCLC

Analysis of driver gene variation in early stage non-small cell lung cancer

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: nonIntervention

Detailed Description

Fluorescence quantitative polymerase chain reaction (PCR) was used to detect the variation of driver gene in regional lymph nodes of early stage non-small cell lung cancer (NSCLC), and to analyze the relationship between the variation and disease recurrence and survival prognosis. evaluate the effect of the variation of driving gene in lymph nodes of early stage NSCLC on prognosis, identify the high-risk factors that promote the recurrence and metastasis of early stage tumor. so as to improve the diagnosis and treatment path of lung cancer, provide important pathological basis for the clinical diagnosis and treatment of early stage non-small cell lung cancer, enable patients to receive more accurate treatment, and improve their survival prognosis.

• Study Type: Observational
• Enrollment (Actual): 237

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

Histologically or cytologically proven diagnosis of early stage NSCLC

Description

Inclusion Criteria:

1. Female or male, 18 years of age or older
2. Histologically or cytologically proven diagnosis of early stage NSCLC
3. The lesion was completely resected by radical surgery
4. Able to get tumor tissue sample
5. Complete information of clinicopathological , survival, recurrence and metastasis can be obtained through follow-up

Exclusion Criteria:

1. Combine with other tumor type
2. The investigator judges the situation that may affect the clinical search process and results

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Driver gene mutation-positive; Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation positive.	Other: nonIntervention; nonIntervention
Driver gene mutation-negative; Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation negative.	Other: nonIntervention; nonIntervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driver gene mutation frequency of early stage NSCLC	Observe the driver gene mutation frequency in regional lymph nodes of early stage non-small cell lung cancer	2019
Correlation of Clinicopathological characteristics and driver gene mutation in regional lymph nodes of early stage NSCLC	Analyze the correlation between driver gene mutation and clinicopathological features in regional lymph nodes of early stage NSCLC	2019
Correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC	Observe the correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC	2019

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Publications and helpful links

General Publications

• Tian Y, Lai Q, Zheng Y, Ying L, Wang C, Jin J, Huang M, Wu Y, Li H, Zhang J, Su D. Oncogenic Alterations in Histologically Negative Lymph Nodes Are Associated with Prognosis of Patients with Stage I Lung Adenocarcinoma. Cancers (Basel). 2022 Feb 6;14(3). pii: 824. doi: 10.3390/cancers14030824.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 9, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Regional Lymph nodes; Molecular metastasis; Driver gene mutation
• 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: LN-OMs

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
• product manufactured in and exported from the U.S.: No