Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients

Study Overview
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Brief Summary
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Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.

Detailed Description
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Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients. We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Official Title
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A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Stage ⅢA Non-small-cell Lung Cancer Patients

Conditions
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Carcinoma, Non-small-cell Lung Cancer, Lung Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 80 years Undergo radical surgery（R0 resection） Histologically confirmed diagnosis of stage ⅢA non-small cell lung cancer Positive Driver mutation(EGFR、PTEN、PIK3CA、BRAF、K-RAS、Her2) in tumor tissue Blood or urine circulating tumor detect the driver mutation detected in tumor tissue Patients must have given written informed consent Exclusion Criteria: Unable to comply with the study procedure Malignant tumor history within the past 5 years Patients who received any treatment prior to resection R1 or R2 resection Coexisting small cell lung cancer Received target drug therapy after surgery Unqualified blood or urine samples

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers |  | 4 years | 
| The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample |  | 1 year | 
| Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis |  | 4 years | 
| Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis |  | 4 years | 
| CtDNA predictive value between locoregional recurrence and distant metastasis |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating Tumor DNA, Lung cancer, lead time