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The GILUPI CellCollectorĀ® 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBC Group | Experimental | metastatic breast cancer Ageļ¼18-75 ECOG:0-2 |
|
| Control Group | Experimental | benign breast tumour Ageļ¼18-75 ECOG:0-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circulating tumor cells | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validation of CellCollector | CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector. | 6 month |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application. | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YH Dong, MD | Contact | +86031189928691 | dongyh_viroad@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 307th Hospital of Chinese People's Liberation Army | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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