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临床试验/NCT07186855
NCT07186855已完成不适用

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
Two-Year Recurrence Status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Age of the patient: ≥18 and ≤75 years; (2) No prior anticancer treatment before surgery; (3) No history of other tumors, past or concurrent; (4) Underwent radical surgery for lung cancer between November 2020 and October 2022; (5) Postoperative pathological diagnosis of non-small cell lung cancer, with staging between Ia and IIIb; (6) Able to comply with study requirements and has signed informed consent.

排除标准

  • (1) Patients with non-small cell lung cancer who have received tumor-related treatments before surgery (including chemotherapy, radiotherapy, targeted therapy, and immunotherapy); (2) Patients with severe cardiac, pulmonary, hepatic, cerebral, or renal dysfunction who are unable to tolerate surgery; (3) Pregnant patients; (4) Patients with concurrent other malignancies; (5) Patients with severe underlying diseases that make them unable to tolerate surgery; (6) Patients with types of lung cancer other than non-small cell lung cancer or with secondary malignant tumors in the lung.

结局指标

主要结局

Two-Year Recurrence Status

时间窗: Up to 2 years after surgery

Time from surgery util recurrence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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