Clinical trial · Observational
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)
NCT07291921CI-TRIAL-00104477recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Minimal Residual Disease | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- High-risk group
- description
- High-risk recurrence groups identified by the multi-omics model
- label
- Low-risk group
- description
- Low-risk recurrence groups identified by the multi-omics model
Primary outcomes (1)
- measure
- Two-year recurrence-free survival rate
- timeFrame
- Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- Time from curative surgery to confirmation of death (any cause),assessed up to 60 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.