NCT07057102

Multiple Omics Sequencing Technologies in Predicting the Efficacy and Monitoring the Recurrence of Non-Small Cell Lung Cancer

Applications of Multiple Omics Sequencing Technologies in Predicting the Efficacy and Monitoring the Recurrence of Non-Small Cell Lung Cancer: A Prospective, Non-Interventional Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer is one of the diseases with the highest global incidence and mortality. Studies have confirmed that liquid biopsy markers such as minimal residual disease (MRD) detection in solid tumors, circulating tumor DNA (ctDNA), and T-cell receptor (TCR) have roles in monitoring disease status, prognostic evaluation, recurrence prediction, and guiding treatment decisions in NSCLC patients. Peripheral blood dynamic monitoring indicators have broad application prospects and may completely transform the treatment paradigm for NSCLC patients in the future. However, current limitations exist, including the need to improve the sensitivity of detection methods, the lack of uniform criteria for defining MRD positivity, the undetermined timing and cycle of MRD testing, and insufficient results from large-scale prospective clinical trials. Therefore, the transition of peripheral blood-based dynamic testing to routine clinical practice still requires results from large-scale prospective clinical trials. This study intends to conduct a prospective clinical trial enrolling NSCLC patients with different stages and treatment modalities (immunotherapy combined with chemotherapy, targeted therapy combined with chemotherapy, neoadjuvant therapy, adjuvant therapy). Based on peripheral blood and tumor tissue samples, it will systematically integrate multi-omics approaches including ctDNA testing, whole exome sequencing (WES), genome-wide methylation sequencing (GM-seq), and TCR-seq to carry out comprehensive, precise, and dynamic biomarker detection for efficacy monitoring and recurrence prediction, providing new methods and evidence for the clinical application of dynamic liquid biopsy monitoring in lung cancer.

Conditions

• Non Small Cell Lung Cancer

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: China