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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Kezhong Chen
• Email: mdkzchen@163.com
• Phone: +86-010-88325983

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.