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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00077843 | Other Identifier | JHMIRB |
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Principal investigator wishes to revisit design and start a new study
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This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group.
Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Experimental | Participants in this arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery). |
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| Control | No Intervention | Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Procedure | Cryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. In the breast, cryoablation is performed under ultrasound guidance. Due to the analgesic properties of freezing, no IV sedation or anesthesia is required. After administration of local anesthetic, the physician makes a 2-3 mm incision and inserts needle-like cryoprobes into the tumor, commencing a number of freeze-thaw cycles. Then the probe is removed, pressure is applied to the area, and a bandage is placed. The patient leaves the office without stitches and minimal, if any, pain. Any residual pain after the procedure is routinely treated with over the counter analgesics such as acetaminophen. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events [safety] | Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes | 1 day after cryoablation |
| Immune response | Immunohistochemical analysis of biomarkers in blood and resected tissue | One week after lumpectomy |
| Cosmetic outcome | Change in appearance based on distortion and volume loss of the breast | Change from one month to one year after lumpectomy |
| Tumor margin status [effectiveness] | Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required | 7-10 days after lumpectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cesar Santa-Maria, MD | Johns Hopkins University | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2018 | Jun 13, 2018 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D018270 | Carcinoma, Ductal, Breast |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
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| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |