NCT03732339已完成不适用
Predictive Value of Circulating Tumor Cells in Neoadjuvant Chemotherapy Among Locally Advanced Breast Cancer Patients: a Single-center, Prospective, Exploratory Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Predictive value of CTC in ypT0 ypN0
研究概览
简要总结
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy
- •Adequate organ function
- •Consent to undergo CTC analysis in vivo
排除标准
- •Pregnant or breastfeeding patients
- •Metastatic or recurrent patients
- •Uncontrollable infection
结局指标
主要结局
Predictive value of CTC in ypT0 ypN0
时间窗: Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy
次要结局
- Detection rate of GILUPI CellCollector®(before and 22-28(±7) days after first dose of neoadjuvant chemotherapy)
- Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR(before and 22-28(±7) days after first dose of neoadjuvant chemotherapy)
- hypersensitivity(up to 1 year)
研究者
Jinsong Lu
Chief of Breast Surgery Department
RenJi Hospital
研究点 (1)
Loading locations...
相似试验
招募中
不适用
CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical TrialCirculating Tumor CellBreast CancerNCT05360290RenJi Hospital484
Unknown
3 期
The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo DeviceCirculating Tumor Cells.BreastNCT03006055Beijing Viroad Biotechnology Co., Ltd.190
已完成
不适用
Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)Prostate CancerColorectal CancerPancreatic CancerGastric CancerBladder CancerRenal Cell CarcinomaAdvanced MET Amplified Solid TumorNon-small Cell Lung CancerNCT02080650Duke University62
招募中
不适用
Determining Circulating Tumour Cells (CTC) and other rare cells in cancer patients and for early detection screeningCancerACTRN12614001143617Dr Karin Ried2,000
招募中
不适用
Cytology-based Circulating Tumour Cell (CTC) Testing in cancer patients and for early detection screening: The ISET-CTC studycancerACTRN12620000986976AProf Dr Karin Ried5,000