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The phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.
The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the treatment response of neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. This study also aims to evaluate the efficacy of CTCs surveillance in predicting invasive-disease free survival (iDFS), overall survival (OS) and metastasis. Additionally, this study evaluate the expression of PDL1 and FOXC3 on CTCs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTC detection | Diagnostic Test | CTCs separation and enrichment technology. Combined with the prognosis of patients with recurrence and survival time, we explored the evaluation of CTC number, cell phenotype distribution, PDL1 and FOXC2 expression on the prognosis of early stage breast cancer patients. The research results are expected to provide a new effective index and theoretical basis for evaluating the treatment efficacy of breast cancer patients. |
| Measure | Description | Time Frame |
|---|---|---|
| iDFS | The survival time from the date of tumor resection to the date of the relapse of the invasive disease. | From date of enrollment through study completion, up to 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | The survival time from the date of recruitment to the date of death. | From date of enrollment through study completion, up to 10 years. |
| Pathological complete response rate | pCR is defined as no infiltrating tumor cells in pathological examination in the primary breast and axillary lymph nodes. |
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Inclusion Criteria
Exclusion Criteria
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Early stage breast cancer patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quchang Ouyang | Contact | +8673189762161 | oyqc1969@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410006 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| From date of enrollment up to 24 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |