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临床试验/NCT07291921
NCT07291921招募中不适用

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)

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月8日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen KeZhong

Professor

Peking University People's Hospital

研究点 (1)

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