NCT05213403已完成不适用
Innovative "Scoring System" in Breast Cancer: a Valid Surgical Choice After Neoadjuvant Chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 255
- 主要终点
- Development of a new scoring system
研究概览
简要总结
Our aim is to create a Scoring System (SS) able of guaranteeing radical oncology by completely removing cancer and aesthetic outcomes in line with the needs or expectations of the patients that helps surgeons to decide the type of surgery in patients undergoing NACT.
Secondary outcome is to assess the ability of the score to avoid neoplastic relapses by evaluating:
- Loco-regional disease free-survival (LR-DFS): months between start of NACT and date of a neoplastic recurrence in residual mammary gland, in ipsilateral chest wall or in ipsilateral axilla.
- Distant disease-free survival (DDFS): months between start of NACT and date of onset of visceral or skeletal metastases.
- Overall survival (OS): months from the start of NACT to death or last follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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 neoadjuvant chemotherapy
- •Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM)
排除标准
- •lack of initial staging or restaging;
- •previous or synchronous history of systemic malignant neoplasms.
- •history of homo-or contralateral breast cancer.
- •initial evidence of metastatic pathology or development of metastases during noeadjuvant chemotherapy (Stage IV)
- •indication to modified radical mastectomy (MRM) without delayed reconstruction
结局指标
主要结局
Development of a new scoring system
时间窗: 2016-2021
Definition of a scoring system aimed to perform the radicality desease and aesthetic outcomes in line with expectance of patients
次要结局
- Evaluation of outcome disease(2016-2021)
研究者
FABI ALESSANDRA
Dr.ssa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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