Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 377
- 试验地点
- 1
- 主要终点
- 2-year recurrence-free survival rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
2-year recurrence-free survival rate
时间窗: Up to 24 months
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.
次要结局
- Median recurrence-free survival(up to 60 months)
研究者
Peng Zhang
Professor
Shanghai Pulmonary Hospital, Shanghai, China