跳至主要内容
临床试验/NCT01978756
NCT01978756已完成不适用

Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.

Maastricht Radiation Oncology1 个研究点 分布在 1 个国家目标入组 387 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
387
试验地点
1
主要终点
The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.

研究概览

简要总结

In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed.

There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival.

The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home.

The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive.
  • Consent to invitation letter and willing to participate.

排除标准

  • Treatment without curative intent.
  • No consent to invitation letter

结局指标

主要结局

The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.

时间窗: One assessment approximately 10 years after radiotherapy

As primary endpoint, for each patients the STAT score will be determined, summarizing locoregional late toxicity, e.g. fibrosis, cosmetic outcome, shoulder dysfunction, lymphedema arm, pain \[Barnett et al, 2012\].

次要结局

  • The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.(One assessment approximately 10 years after radiotherapy)

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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