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To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In order to facilitate the validation process, investigators will only focus on metastatic patients for whom CTCs supposedly present at higher abundance. Investigators propose to enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. The specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. Investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and CTC analysis algorithm. During this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| first stage | During the first stage, the patient's baseline blood sample will be mainly used for validating and troubleshooting our instrument with clinical samples. | ||
| second stage | During the second stage, 40 patients will be followed for up to three years after their baseline blood draw to obtain data on their survival status. The CTC results and follow-up data obtained from these samples will help to analyze any correlation with the patient's clinical outcome and further validate the prognosis ability of MiCareo's CTC platform for mBC patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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metastatic breast cancer (mBC) patients
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| Name | Affiliation | Role |
|---|---|---|
| Chen Jui-Lin | CEO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung Memorial Hospital | Keelung | Taiwan |
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| ID | Term |
|---|---|
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |