NCT06081777

Significance of MRD Monitoring in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer

A Study Evaluating MRD Biomarker in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline tissues, Peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients with potentially resectable stage III non-small cell lung cancer.

Detailed description

In this prospective study, 65 patients with potentially operable non-small cell lung cancer without driving gene EGFR/ALK mutation in stage III were enrolled in this prospective study. peripheral blood samples from multiple nodes after neoadjuvant therapy, postoperative (if any), adjuvant therapy and follow-up were collected and analyzed by high-throughput sequencing in the target region. Patients were enrolled in the study for 1 year, followed up for 2 years, and the study lasted for 3 years. The patients were followed up for 2 years according to the standard diagnosis and treatment path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of the standard diagnosis and treatment path, and the follow-up examination was conducted in accordance with clinical standards.

Conditions

• NSCLC

Timeline

• Start date: 2022-11-25
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: China