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Operable early stage breast cancer patients staged according to NCCN guidelines are subjected to bone marrow aspiration/trephine biopsy at the time of the definitive operation under general anesthesia. The specimen will be fixated in neutral tamponaded formalin and the sections will be examined by H&E and cytokeratin immunohistochemically. If disseminated tumor cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will be studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively. Results of the pilot study will be evaluated as observational study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all | Other | All patients with early breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bone marrow aspiration /trephine biopsy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of bone marrow metastases in early stage breast cancer | Number of patients with bone marrow metastases/ total number of enrolled patients | up to 5 years |
| Rate of sentinel lymph node metastases in early stage breast cancer | up to 5 years | |
| Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer | up to 5 years | |
| Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer | up to 5 years | |
| Incidence of bone marrow metastases in triple negative early stage breast cancer | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy | Up to 10 years | |
| Overall survival | up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | up to 10 years |
Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acibadem University School of Medicine | Recruiting | Istanbul | 34515 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |