RecruitingNCT07291921

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)

Sponsor

Peking University People's Hospital

Enrollment

100 participants

Start Date

May 8, 2025

Study Type

OBSERVATIONAL

Conditions

Neoadjuvant Therapy Lung Neoplasms Minimal Residual Disease Immunotherapy

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

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.

Exclusion Criteria9

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).