Circulating Tumor Cells Spillage After Pulmonary Biopsy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Circulating tumor cells (CTCs) before and after the procedure.
研究概览
简要总结
The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.
详细描述
Introduction:
Lung cancer (NSCLC) is a common malignancy with a high recurrence rate even when diagnosed at early stages. Biopsy is currently the procedure of choice for the investigation of pulmonary lesions, yet it is unclear whether the biopsy itself releases tumor cells into the circulation and attributes to the late distal recurrence.
Studies of various malignancies show the ability to identify circulating tumor cells (CTCs) even in early stage cancer. The number of CTCs correlates with disease outcome. Dynamics of CTCs after CT or bronchoscopy guided biopsy has not been evaluated so far. In the metastatic setting, the number of CTCs correlates to tumor response to chemotherapy in both small and non-small lung cancer (SCLC and NSCLC, respectively).
The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.
Patients with suspected pulmonary lesions undergoing CT or bronchoscopy guided biopsy will be enrolled into the study. The CellCollectorTM will be used for CTCs detection before and after the procedure. These patients will be their own controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of lung cancer
- •Patients are designated to undertake biopsy
- •Able and willing to participate in this study
- •Availability of a signed informed consent
排除标准
- •Any recent non-lung cancer in the recent 2 years.
研究组 & 干预措施
biopsy
needle will be inserted before and after biopsy and will measure circulating tumor cells.
干预措施: CellCollectorTM (Gilupi, Germany) needle (Device)
结局指标
主要结局
Circulating tumor cells (CTCs) before and after the procedure.
时间窗: 1 day
In this study we will use for CTC counting the CellCollectorTM (Gilupi, Germany) needle that isolates CTCs of epithelial origin using a needle coated with antibodies directed against the epithelial cell adhesion molecules (EpCAM).
次要结局
未报告次要终点
研究者
Nir Peled
Professor
Rabin Medical Center