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)
Recruiting · NCT07291921 · Observational (researchers observe without assigning treatment) · Lead sponsor: Peking University People's Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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).
Where it is running
1 location listed.
- Peking University People's Hospital - Beijing, Beijing Municipality, China