Exploration on the Value of MRD Based on ctDNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on lung cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The panel is used to detect molecular residual disease of stage IB-IIIB non-small cell lung cancer patients underwent radical surgery, explore personalized analysis models, and conduct research on recurrence monitoring for non-small cell lung cancer patients.

Official Title
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Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old, regardless of gender; Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB; Able to undergo radical surgical treatment; Physical condition score (ECOG) ≤1; The expected survival time exceeds 24 months; Volunteer to participate in this study and sign an informed consent form. Exclusion Criteria: Individuals with a history of other malignant tumors within 5 years; Those who have undergone neoadjuvant therapy before surgery; Postoperative incision margin R1 or incision margin R2; Those who have undergone a blood transfusion within 2 weeks before the surgery; Individuals with systemic inflammatory response syndrome; Those with serious diseases of important organs such as the heart, lungs, kidneys, and brain; Participants in other clinical trials within the past 30 days and have taken investigational drugs; Due to various reasons, sampling cannot be completed, samples do not meet the requirements, or baseline samples (preoperative and postoperative plasma samples, tumor tissue samples) are incomplete; Researchers believe that it is not appropriate to participate in this experiment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 |
| --- | --- | --- |
| 2-year recurrence-free survival rate | Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. 2-year recurrence-free survival rate means the rate of patients survive without recurrence for 2 years or more. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median recurrence-free survival | Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. Median recurrence-free survival means the median value of recurrence-free survival. | up to 60 months |