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This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Following pre-procedural imaging evaluation, patients will receive ultrasound-guided percutaneous cryoablation as part of their routine treatment of their breast cancer. Follow up imaging (if tolerated) will be performed at 6 months and 12 months and annually thereafter for until 3 years post-procedure. Data will be collected on patient demographics, disease characteristics, treatment, treatment complications, follow-up imaging, response (for 3 years post-procedure), and quality of life. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Device | Takes place at single time point. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0 | Through 3 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who demonstrate progression-free survival (PFS) | At 3 year follow-up | |
| Proportion of patients who demonstrate disease-free survival (DFS) | At 3 year follow-up | |
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Eligibility Criteria:
Diagnosis of breast cancer.
Mass must be visible on ultrasound and > 5 mm from skin.
Not undergoing surgery, because:
At least 18 years old.
Able to understand and willing to sign an IRB-approved written informed consent document.
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Patients seen at Siteman Cancer Center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather Garrett, M.D. | Contact | 314-454-5206 | hvgarrett@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heather Garrett, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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In addition to the analyses proposed in this protocol, the data collected under this registry will be stored for potential (currently unknown) research projects and may be used to query for feasibility of future projects and other quality initiatives.
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Requests from individuals outside Washington University will require a formal data use agreement (DUA) before release of data for limited data sets and/or identifiable data sets.
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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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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Proportion of patients who demonstrate overall survival (OS) |
| At 3 year follow-up |
| D017437 |
| Skin and Connective Tissue Diseases |