Monitoring of Circulating Tumor DNA and Its Aberrant Methylation in the Surveillance of Surgical Lung Cancer Patients (MEDAL, MEthylation Based Dynamic Analysis for Lung Cancer).

Study Overview
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Brief Summary
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Conduct a prospective study to confirm the value of circulating tumor DNA and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients.

Detailed Description
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Studies have already demonstrated the feasibility of circulating tumor DNA as a surrogate to reveal tumor mutation status in lung cancer patients and a few researches have shown the potential ability of using circulating tumor DNA in surveillance. However, no study focused on the value of methylation status of circulating tumor DNA in the surveillance and no strict prospective study has been performed in surgical lung cancer patients. The investigators plan to analyze the dynamic change of circulating tumor DNA and its methylation status longitudinally from preoperation to long term follow-up in surgical lung cancer patients, and compare assessment value between circulating tumor DNA detection with methylation , traditional imaging examinations and traditional blood tumor markers in the monitoring process.

Official Title
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A Prospective Study of Longitudinal Monitoring in Surgical Lung Cancer Patients by Circulating Tumor DNA and Its Methylation

Conditions
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Carcinoma, Lung Cancer, NSCLC, Lung Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 80 years Lung cancer was suspected preoperatively. Received curative surgical therapy No malignant tumor history within the past 5 years No being received any treatment prior to resection Patients must have given written informed consent Exclusion Criteria: The pulmonary nodule is pure ground glass opacity Unable to comply with the study procedure The postoperative pathology is not NSCLC. Unqualified blood 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 |
| --- | --- | --- |
| Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concordance of ctDNA genomic and methylation status alterations detected in peripheral blood samples with those in matched tumor samples. | Concordance will be defined as matched ctDNA and tumor DNA has the same identified mutations (methylation status alterations) or has no mutation (methylation status alteration). Concordance rate (%) will be calculated by consistent patient number and total patient number. | 1 year | 
| The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery. |  | 1 year | 
| Correlation between disease free time and quantitative detection of ctDNA genomic alterations or methylation status alterations in patients who receives adjuvant therapy. |  | 3 years | 
| Leading time of tumor relapse detection by circulating tumor DNA and methylation status than traditional radiological methods. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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circulating tumor DNA, ctDNA methylation, lung cancer, surveillance