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

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: nonIntervention

• Registration Number: NCT04266691
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2015-12
• Study Completion: 2019-06
• Status Verified: 2020-02
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-09
• Last Update Submitted: 2020-02-09
• Study First Posted: 2020-02-12
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Driver gene mutation-positive	nonIntervention	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.
Driver gene mutation-negative	nonIntervention	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.

Primary Outcome Measures

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