Spatial Location of Breast Cancer Local Recurrence After Mastectomy: the Secret Study, a Retrospective Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Spatial localisation of local recurrences
研究概览
简要总结
Rationale:To improve the definition of the target volume for radiotherapy of the chestwall after different types of mastectomy, the exact localization of regions at risk for a local recurrence should be known. However, there are currently insufficient data in literature showing where local recurrences occur after different types of mastectomy.
Objective: The primary objective of the proposed study is to determine whether the spatial, location of a breast cancer recurrence after mastectomy, differs for different types of mastectomy.
Study design: Retrospective study evaluating spatial location and site of recurrences after mastectomy.
Study population: The investigators aim to include all breast cancer patients treated with mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local recurrence as the first site of failure.
Primary endpoint: Spatial location of local recurrence (e.g., primary tumour bed, scar, skin, subcutaneous, nipple, areola, pectoral muscles).
详细描述
Rationale:To improve the definition of the target volume for radiotherapy of the chestwall after different types of mastectomy, the exact localization of regions at risk for a local recurrence should be known. However, there are currently insufficient data in literature showing where local recurrences occur after different types of mastectomy.
Objective: The primary objective of the proposed study is to determine whether the spatial, location of a breast cancer recurrence after mastectomy, differs for different types of mastectomy. Secondary objectives are to assess whether tumour characteristics (e.g., molecular subtypes, lymphangio/lymphovascular invasion) and treatment-related factors (e.g., PMRTwith or without bolus, radiation volumes, doses) influence the site of recurrence and spatial location.
Study design: Retrospective study evaluating spatial location and site of recurrences after mastectomy.
Study population: The investigators aim to include all breast cancer patients treated with mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local recurrence as the first site of failure.
Primary endpoint: Primary endpoint: Spatial location of local recurrence (e.g., primary tumour bed, scar, skin, subcutaneous, nipple, areola, pectoral muscles).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age 18 years and more at the time of breast cancer diagnosis.
- •Proven histology of first invasive breast cancer
- •Mastectomy as a surgical procedure for breast cancer (regardless of perioperative treatment).
- •Having a local recurrence, as primary event
- •reast cancer diagnosis in the period 2003-2008.
排除标准
- •Non-epithelial histology.
- •Primary metastatic breast cancer.
- •Mastectomy for breast cancer recurrence after earlier breast conserving therapy.
- •Synchronous breast cancer.
结局指标
主要结局
Spatial localisation of local recurrences
时间窗: Up to 15 years after mastectomy
The primary objective of the proposed study is to determine whether the spatial, location of a breast cancer recurrence after mastectomy, differs for different types of mastectomy.
次要结局
- Influence of tumour characteristics on the site of recurrence and spatial location.(Up to 15 years after mastectomy)
- Influence of treatment-related factors on the site of recurrence and spatial location.(Up to 15 years after mastectomy)