James W. Jakub, M.D.

The purpose of this retrospective study is to evaluate the complication rate of prophylactic open NSM procedures through 42 days follow-up from retrospective chart review at the same investigators and institutions as those included under IDE Study protocol G190065/A001.

The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.

This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).

Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).

Hypothesis: Patients undergoing NSM will be willing to enroll in a randomized trial to determine if neurotization improves patient-reported satisfaction outcomes and improves sensation, compared with nipple sparing mastectomy without neurotization.

1. Primary Objective

To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.

2. Secondary Objectives

1. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.
2. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.
3. To determine rate of mastectomy skin flap necrosis following NSM via the SKIN score.

The purpose of this study is to establish a tissue bank to collect patient tissue for genomic analysis, allowing identification of genomic signatures that predict response and failure to the individual therapy.  Once this is complete treatment will be directed based on the genomic signature of patients individual tumor.

The purpose of this study is to evaluate the safety and effectiveness of the da Vinci Surgical Systems in Nipple Sparing Mastectomy procedures.

The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.

The purpose of this study is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical’s cavity ring-down spectrometer, the goal is to further develop Breathe BioMedical’s technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women with dense breast tissue.

The purpose of this study is to determine the overall prevalence and types of germline genetic mutations in a contemporary multi-institutional cohort of women diagnosed with a phyllodes (connective tissue) tumor of the breast, to compare the overall rate and types of germline genetic mutations observed in a multi-institutional cohort of women with phyllodes tumors to the average population and women with breast cancer, and to compare the rate and types of germline genetic mutations identified between each of the histologic subtypes (grade) of phyllodes tumors (benign, borderline, malignant).

The purpose of this study is to evaluate the safety and effectiveness of the da Vinci Surgical Systems in Nipple Sparing Mastectomy procedures.

The purpose of this study is to evaluate the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

The purpsoe of this study is to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.

The purpose of this study is to compare a vaccine with autologous tumor lysate loaded into yeast cell wall particles that are naturally and efficiently taken up into a patient's dendrite cells to a placebo without the autologous tumor lysate. The vaccine is formulated to treat stage III or IV resected melanoma to prevent recurrence.

The purpose of this study is to assess whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves the ability to evaluate tumors and decide what kind of surgery is best for the patient.

The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operative technique is safe.

The purpose of this study is to establish a tissue bank to collect patient tissue for genomic analysis, allowing identification of genomic signatures that predict response and failure to the individual therapy.  Once this is complete treatment will be directed based on the genomic signature of patients individual tumor.

The sentinel lymph nodes in patients with melanoma are immunosuppressed and the investigators have shown this occurs early in the disease process. This regional nodal immunosuppression precedes nodal metastasis and may be required for nodal spread. Administration of GM-CSF has been used to alter the immune response to metastatic melanoma. The investigators propose to assess whether administration of a short course of GM-CSF preoperatively to patients about to undergo wide local excisions and sentinel lymph node dissection can alter the immune environment of the sentinel lymph node and restore an immune surveillance profile in the sentinel lymph node.

The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.