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临床试验/NCT06130111
NCT06130111进行中(未招募)不适用

Spatial Location of Breast Cancer Local Recurrence After Mastectomy: the Secret Study, a Retrospective Analysis.

Maastricht Radiation Oncology1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2021年9月1日最近更新:
适应症

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

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)

研究者

发起方
Maastricht Radiation Oncology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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