The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device
Phase 3
- Conditions
- Circulating Tumor Cells.Breast
- Interventions
- Device: Circulating tumor cells
- Registration Number
- NCT03006055
- Lead Sponsor
- Beijing Viroad Biotechnology Co., Ltd.
- Brief Summary
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE approved. Application data of CellCollector in China is not available now. The purpose of this clinical trial is to confirm the validation and safety of CellCollector in Chinese patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 190
Inclusion Criteria
- Metastasis breast cancer confirmed with imaging examination
- Have agreed to undergo CTC analysis in vivo;
- ECOG：0-2
Exclusion Criteria
- Non-metastasis breast cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Group Circulating tumor cells benign breast tumour Age：18-75 ECOG:0-2 MBC Group Circulating tumor cells metastatic breast cancer Age：18-75 ECOG:0-2
- Primary Outcome Measures
Name Time Method Validation of CellCollector 6 month CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 6 month Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The 307th Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China