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| ID | Type | Description | Link |
|---|---|---|---|
| WCI1659-09 | Other Identifier | Other |
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The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation.
At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Conserving Surgery (BCS) | Active Comparator |
| |
| Breast Conserving Surgery with Additional 5 Margins (BCS + M) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remove tumor only | Procedure | No additional margins (tissue) removed at the initial surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing 2 surgical methods for treatment of early stage breast cancer | The investigator will survey patients with the cosmetic assessment survey after the surgical procedure. | Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica Rizzo, MD | EmoryUniversity Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
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| Removal of tumor and tissue | Procedure | 5 additional margins (tissue) removed at the time of surgery |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D006650 | Histocompatibility Testing |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
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