NCT07186855

Perioperative and Postoperative Circulating Tumor Cell Monitoring in Different Stage of NSCLC

The Study on the Relationship Between Perioperative and Postoperative Circulating Tumor Cell Monitoring and Prognosis in Patients With Non-Small Cell Lung Cancer at Different Stages

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

The study aims to enroll 500 non-small cell lung cancer patients at various stages and to employ this technology for CTC detection, with subsequent cytomorphological and chromosomal analysis of the isolated CTCs, and comprehensively assess the utility of this CTC monitoring technology in predicting postoperative recurrence, metastasis, and survival in non-small cell lung cancer patients across different stages.

Detailed description

Lung cancer currently has the highest incidence and mortality rates among malignant tumors in China. Distant metastasis is one of the main causes of death in lung cancer patients, with hematogenous dissemination being the primary pathway for lung cancer metastasis. Theoretically, even at the carcinoma in situ stage, cancer cells can disseminate into the peripheral blood, forming circulating tumor cells (CTCs), thus playing a critical role in the process of distant metastasis in lung cancer. Early diagnosis and monitoring of recurrence and metastasis are essential for improving patient survival rates. Traditional methods for monitoring postoperative recurrence and metastasis in lung cancer patients rely primarily on imaging studies; however, by the time recurrence or metastasis is detected through imaging, the disease is often at an advanced stage, leading to suboptimal treatment outcomes. Previous studies have shown that changes in CTC levels usually precede the appearance of detectable lesions on imaging. Therefore, CTC level monitoring can predict recurrence, metastasis, treatment response, and prognosis in lung cancer patients. As a form of "liquid biopsy," CTC testing can provide timely insights into a patient's disease status and offer better individualized treatment strategies for lung cancer patients. This study utilizes the viral tracing method developed by our research team, which holds independent intellectual property rights, as the primary technology. In addition, microfluidic technology has been introduced upstream in the workflow to initially screen and enrich CTCs, followed by ex vivo identification and characterization of the captured CTCs. The study aims to enroll 500 non-small cell lung cancer patients at various stages and to employ this technology for CTC detection, with subsequent cytomorphological and chromosomal analysis of the isolated CTCs. Finally, by integrating preoperative and postoperative imaging data, pathological findings, and recurrence, metastasis, and survival outcomes, we will comprehensively assess the utility of this CTC monitoring technology in predicting postoperative recurrence, metastasis, and survival in non-small cell lung cancer patients across different stages.

Conditions

• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
OTHER	Blood Sample Collection for CTC Detection	Blood Sample Collection for CTC Detection

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: China