SKINI - Prospective Evaluation of the Radicality of Breast Tissue Removal With Skin-Sparing and Nipple-Sparing Mastectomy (SSM or NSM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Detection of residual breast tissue (RBT)
研究概览
简要总结
Prospective collection of health related personal data and biological material (tissue biopsy) in patients undergoing mastectomy.
详细描述
In this prospective, multi-center trial patients undergoing mastectomy and fulfilling inclusion criteria receive additional biopsies from the remaining skin envelope in order to quantify the amount of residual breast tissue.
Since the investigators will assess, 142 breasts will be investigated. This means a maximum of n=142 patients will be included (corresponding to a minimum of n=71 patient).
On the specimen additional histological sections in radial direction will be performed.
The aim of the study is to evaluate the quality of Skin- Sparing and Nipple-Sparing Mastectomy. On each predefined location in the wound cavity the investigators will investigate where residual breast tissue (RBT) will be found or not. If no RBT can be detected at all predefined breast locations this breast will be classified as having no RBT (=RBT negative). If breast tissue can be detected the investigators have a RBT positive breast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing uni- or bilateral Skin-Sparing or Nipple-Sparing mastectomy
- •Female participants ≥ 18 years of age
- •The subject was informed on the project and gave her written informed consent to use her data and samples for this project.
排除标准
- •Not fulfilling inclusion criteria
研究组 & 干预措施
Skin-Sparing Mastectomy (SSM)
干预措施: Skin-Sparing Mastectomy (SSM) (Procedure)
Nipple-Sparing Mastectomy (NSM)
干预措施: Nipple-Sparing Mastectomy (NSM) (Procedure)
结局指标
主要结局
Detection of residual breast tissue (RBT)
时间窗: 20 months
Each biopsy specimen will be histopathologically assessed for the presence of residual breast tissue (RBT), i.e. in case of SSM 10 biopsy specimens (points A-K) and in case of NSM 14 biopsy specimens (points A-O). A mastectomy is defined as RBT-positive whenever residual breast tissue will be detected in one or more biopsies. RBT will be assessed as binary dependent variable (0: no RBT; 1: at least one probe with positive breast tissue detection) and correlated with patient- and therapy-related factors, including age, BMI, breast weight, side of mastectomy (left vs. right), type of mastectomy (SSM vs. NSM), skin flap necrosis, indication for mastectomy, axilla surgery, preoperative treatment, surgeon, incision type as well as distance between surface of removed breast and glandular tissue. Presence of RBT will also be assessed with regard to the distribution within the points A-O and the percentage of RBT-positive biopsies of the entity of all biopsies.
次要结局
- Distance between surface of the removed breast and glandular tissue(20 months)
- Detection of residual disease(20 months)
- Correlation of patient- and therapy-related factors with residual breast tissue (RBT) and with distance between surface of removed breast and glandular tissue(20 months)