To Conduct Multi-omics Integrated Studies in Peripheral Blood, Such as Fragment Omics, Metabolomics and Epigenetics, and Establish Non-invasive Dynamic Follow-up Monitoring Programs During Perioperative and Postoperative Periods (Observational Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Two-year recurrence-free survival rate
研究概览
简要总结
This project aims to innovatively integrate multi-omics data, including plasma metabolomics, radiomics, and cfDNA multi-level information, combined with survival data (e.g., RFS), to establish a novel multidimensional approach for noninvasive postoperative recurrence monitoring in lung cancer using artificial intelligence algorithms. The goal is to develop a new noninvasive recurrence monitoring system for lung cancer.
详细描述
This project is a prospective observational study designed to comprehensively integrate plasma metabolomic, radiomic, and epigenomic data to develop a predictive model for postoperative recurrence risk in lung cancer. The study will retrospectively enroll 200 patients who underwent radical surgery after neoadjuvant therapy, and prospectively enroll 100 additional post-radical-surgery lung cancer patients who received neoadjuvant treatment as a validation cohort. Peripheral blood samples will be collected at multiple timepoints for metabolomic profiling. Unsupervised clustering, random forest algorithms, and Wilcoxon tests will be applied to identify recurrence-related features and construct a recurrence prediction model.Additionally, using preoperative and first postoperative follow-up CT imaging data, a deep learning-based 3D ResNet will be employed to generate radiomic recurrence risk scores for each patient. Plasma cfDNA will undergo low-pass whole-genome sequencing and methylation analysis to extract multi-dimensional recurrence-associated features. Finally, the study will innovatively utilize the DeepProg deep learning framework to integrate radiomic, cfDNA, and plasma metabolomic data into a non-invasive multi-omics model. Combined with survival data, this model will predict recurrence risk, ultimately achieving high-accuracy stratification of patients' postoperative recurrence probability.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Male or female, aged ≥ 18 and < 85 years.
- •Radical resection performed, pathologic stage IB-IIIA (8th TNM) non-small-cell lung cancer.
- •Tumor tissue and blood samples obtainable at all protocol-specified time-points.
- •No pure ground-glass nodule on imaging.
- •Completed standard neoadjuvant immunotherapy combined with platinum-based chemotherapy.
排除标准
- •Postoperative pathology shows other than NSCLC, including but not limited to benign lesions, small-cell carcinoma, metastasis, or indeterminate/inadequate histology.
- •Insufficient or poor-quality blood or tissue samples.
- •Pure ground-glass nodule on imaging.
- •History of any malignancy within the past 5 years.
- •Contraindication to surgery preventing radical resection.
- •Non-radical (R2) resection.
- •Pathologic stage IIIB-N3, IIIC, or IV on paraffin sections.
- •Refusal or withdrawal of informed consent.
- •Any condition deemed unsuitable by the investigator (e.g., perioperative blood transfusion, severe psychiatric disorder precluding follow-up).
研究组 & 干预措施
High-risk group
High-risk recurrence groups identified by the multi-omics model
Low-risk group
Low-risk recurrence groups identified by the multi-omics model
结局指标
主要结局
Two-year recurrence-free survival rate
时间窗: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years
次要结局
- Overall survival(Time from curative surgery to confirmation of death (any cause),assessed up to 60 months.)
- Timely diagnosis rate by the novel MRD monitoring technique(two years)
研究者
Chen KeZhong
Professor
Peking University People's Hospital
