Multi-omics blood and CT monitoring for early detection of lung cancer recurrence after neoadjuvant therapy and surgery

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)

This project tests whether combining blood-based multi-omics (metabolomics and cfDNA), CT radiomics, and AI can noninvasively detect early recurrence after surgery in NSCLC patients treated with neoadjuvant immunotherapy.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07291921 on ClinicalTrials.gov

What this trial studies

This prospective observational project integrates plasma metabolomics, low-pass whole-genome and methylation cfDNA profiling, and CT-based radiomics to build a noninvasive recurrence prediction model for resected NSCLC. The protocol will retrospectively analyze 200 patients and prospectively enroll 100 additional patients who underwent radical resection after neoadjuvant immunotherapy plus platinum chemotherapy, with peripheral blood collected at multiple perioperative and postoperative timepoints. Machine-learning methods (unsupervised clustering, random forest, Wilcoxon tests) and a 3D ResNet radiomic pipeline will generate recurrence-associated features, which will be combined using the DeepProg deep-learning framework alongside relapse-free survival outcomes. The final integrated model aims to stratify postoperative recurrence risk and support dynamic, noninvasive follow-up monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults (18–<85 years) with pathologic stage IB–IIIA NSCLC who had radical resection after standard neoadjuvant immunotherapy plus platinum-based chemotherapy and can provide tumor tissue and serial blood samples.

Not a fit: Patients with non-NSCLC histology, stage IIIB–IV disease, R2 (non-radical) resection, pure ground-glass nodules, recent other malignancies, or inadequate/low-quality tissue or blood samples are unlikely to benefit.

Why it matters

Potential benefit: If successful, the approach could allow earlier, noninvasive detection of recurrence to personalize surveillance and adjuvant treatment decisions.

How similar studies have performed: Previous work using cfDNA-based MRD testing and radiomic signatures has shown promising predictive ability for recurrence, but fully integrated multi-omics AI models combining metabolomics, methylation, low-pass WGS, and radiomics remain largely exploratory.

Eligibility criteria

Inclusion Criteria:

1. Signed written informed consent.
2. Male or female, aged ≥ 18 and \< 85 years.
3. Radical resection performed, pathologic stage IB-IIIA (8th TNM) non-small-cell lung cancer.
4. Tumor tissue and blood samples obtainable at all protocol-specified time-points.
5. No pure ground-glass nodule on imaging.
6. Completed standard neoadjuvant immunotherapy combined with platinum-based chemotherapy.

Exclusion Criteria:

1. Postoperative pathology shows other than NSCLC, including but not limited to benign lesions, small-cell carcinoma, metastasis, or indeterminate/inadequate histology.
2. Insufficient or poor-quality blood or tissue samples.
3. Pure ground-glass nodule on imaging.
4. History of any malignancy within the past 5 years.
5. Contraindication to surgery preventing radical resection.
6. Non-radical (R2) resection.
7. Pathologic stage IIIB-N3, IIIC, or IV on paraffin sections.
8. Refusal or withdrawal of informed consent.
9. Any condition deemed unsuitable by the investigator (e.g., perioperative blood transfusion, severe psychiatric disorder precluding follow-up).

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Kezhong Chen

Conditions Lung Neoplasms; Neoadjuvant Therapy; Immunotherapy; Minimal Residual Disease; NSCLC; Neoadjuvant immunotherapy; Perioperative monitoring; Liquid biopsy