Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.
Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.
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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Limburg
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Maastricht、Limburg、荷兰、6200 XW
- Maastro clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Treatment without curative intent.
- No consent to invitation letter
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Outpatient clinic
All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive, who respond to our invitation letter and are willing to participate to visit the outpatient clinic.
These patients will be sent a questionnaire with both basic and more detailed questions on their disease-status and on quality of life related outcome.
In addition they will be asked to come to MAASTRO clinic for a more detailed evaluation of late side effects of the treatment.
Patients are seen by a physician or a physician assistant at the outpatient clinic.
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The participants are seen at the outpatient clinic by a physician or a physician assistant.
To analyse fibrosis clinical examination of the breast will be performed.
To analyse shoulder function anteversion / retroversion, abduction / adduction and internal / external rotation will be measured.
To analyse edema the arm circumference will be measured 15 cm above and below the medial epicondyle (both sides).
Also, a photograph of the breast will be made for cosmetic analysis using standardized procedures.
Finally a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
大体时间：One assessment approximately 10 years after radiotherapy
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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].
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One assessment approximately 10 years after radiotherapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.
大体时间：One assessment approximately 10 years after radiotherapy
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The secondary endpoint is 10 year survival rate, and late toxicity, other than locoregional late toxicity, e.g.
fatigue, neuropathy, menopausal symptoms, cardiac and pulmonary symptoms, and secondary tumors.
Survival will be divided in overall survival, locoregional recurrence free survival and distant metastases free survival.
For each patient other toxicity at 10 year will be scored according to CTC-AE 4.
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One assessment approximately 10 years after radiotherapy
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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In addition, we will record potential risk factors for the several outcome parameters
大体时间：one consultation by physician (assistant) ten years after radiotherapy
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The following the potential risk factors are recorded:
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one consultation by physician (assistant) ten years after radiotherapy
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合作者和调查者
调查人员
- 首席研究员：Liesbeth J Boersma, M.D., Ph.D.、Maastro Clinic, The Netherlands
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Outpatient clinic的临床试验
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McMaster UniversityCanadian Institutes of Health Research (CIHR); Hamilton Academic Health Sciences Organization完全的
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Transitions ClinicUniversity of California, Davis完全的
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University of North Carolina, Chapel HillMinistry of Public Health, Democratic Republic of the Congo; Kinshasa School of Public Health... 和其他合作者完全的
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Massachusetts General HospitalBeth Israel Deaconess Medical Center; Boston Children's Hospital; Brigham and Women's Hospital招聘中