Circulating Tumor Cells.Breast
Conditions
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.
Interventions
DEVICECirculating tumor cells
Sponsors
Beijing Viroad Biotechnology Co., Ltd.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYH Dong, MD
Outcome results
None listed