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| ID | Type | Description | Link |
|---|---|---|---|
| IRB202500675 | Other Identifier | University of Florida |
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This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following oncoplastic surgery. Our proposed cavity marking schema will allow radiation oncology to identify the cavity margins more accurately on CT simulation for radiation planning and delivery. This cavity marking schema also provides more accurate margin identification in patients recommended for re-excision of close or positive margins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel cavity marking technique during breast conservation surgery with oncoplastic reconstruction | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel cavity marking technique | Procedure | A novel cavity marking technique will be performed on all participants during their breast conservation surgery. For this technique, cavity marking will be in a clockwise fashion per breast starting with the superior margin of the tumor bed. The superior margin of the left breast will be marked with a single large clip, followed by a double clip for the lateral margin, a triple clip for the inferior margin, and a quadruple clip for the medial margin. The superior margin of the right breast will be marked with a single large clip, followed by a double clip for the medial margin, a triple clip for the inferior margin and a quadruple clip for the lateral margin. Margins with multiple clips will always have one large clip with the remaining clips standard medium size. |
| Measure | Description | Time Frame |
|---|---|---|
| Confidence rating in cavity identification | Determine the percentage of patients that receive each of three possible confidence ratings ("Confident", "Informative", and "Ambiguous") from radiation oncologists for their confidence in being able to identify the surgical cavity on imaging. | Within 8 weeks of surgery if patient does not receive adjuvant chemotherapy or within 8 weeks following adjuvant chemotherapy (~4-6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients needing re-excision | Determine the percentage of patients needing re-excision | 7-14 days post-surgery |
| Local disease recurrence rate | Determine the percentage of patients that have local disease recurrence at 2 years post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Portillo | Contact | 352-273-3650 | portillos@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Spiguel, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32608 | United States |
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|
| 2 years post-surgery |
| Median overall survival rate | Determine the median overall survival rate at 2 years post-surgery. | 2 years post-surgery |
| Median recurrence-free survival rate | Determine the median recurrence-free survival rate at 2 years post-surgery. | 2 years post-surgery |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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