Analysis of Driver Gene Mutation in Early Stage Non-small Cell Lung Cancer
February 9, 2020 updated by: zjszlyyad@126.com, Zhejiang Cancer Hospital
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
Intervention / Treatment
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- Female or male, 18 years of age or older
- Histologically or cytologically proven diagnosis of early stage NSCLC
- The lesion was completely resected by radical surgery
- Able to get tumor tissue sample
- Complete information of clinicopathological , survival, recurrence and metastasis can be obtained through follow-up
Exclusion Criteria:
- Combine with other tumor type
- The investigator judges the situation that may affect the clinical search process and results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
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.
|
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.
|
nonIntervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Driver gene mutation frequency of early stage NSCLC
Time Frame: 2019
|
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
Time Frame: 2019
|
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
Time Frame: 2019
|
Observe the correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC
|
2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.