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Currently, there is no standard recommendation for using imaging studies to check patients for breast cancer recurrence who have been treated with mastectomy. The investigator proposes performing in-office ultrasound examinations of these patients to determine if this would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences following mastectomy.
The investigator hypothesizes that surgeon-directed ultrasound is a feasible, accurate, and cost-effective strategy for local recurrence surveillance in breast cancer patients after mastectomy. Toward examining these hypotheses, the investigators propose the following Specific Aims:
Aim I: To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.
Aim II: To determine the sensitivity and specificity of surgeon-performed ultrasound for the detection of post-mastectomy breast cancer recurrence.
Aim III: To estimate the cost of performing surgeon-directed ultrasound for the detection of post-mastectomy breast cancer recurrence from the perspective of a third party payer relative to standard surveillance alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Experimental | post mastectomy ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| post mastectomy ultrasound | Device | post mastectomy ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound. | To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound during a three year trial period. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity of surgeon performed breast ultrasound to detect breast cancer recurrence after mastectomy will be measured. | Sensitivity measures the proportion of patients that have pathologically confirmed breast cancer recurrences that were correctly identified as such by surgeon performed ultrasound. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Martinez, MD, MAS,FACS | Providence Health & Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | United States |
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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 |