Does Anesthesia Technique Impact on the Long-term Outcome 5 and 10 Years After the First Intervention in Primary Breast Cancer Surgery? A Follow-up Analysis. (CTC follow up)
研究概览
详细说明
It has been assumed that the type of general anesthesia impacts the release of circulating tumor cells (CTC) in the perioperative setting of breast cancer surgery. Those CTC are suspected to promote metastasis formation. We have already investigated the direct effect of sevoflurane vs. propofol on CTC in a randomized controlled trial. There was no significant difference in the number of CTC between the two treatment groups up to 72 hours after anesthesia.
CTC are a surrogate marker for cancer recurrence. Therefore, the role of the choice of the general anesthetic for breast cancer surgery should be clarified focusing on the long-term clinical outcome. In this follow-up study, we aim at defining the cancer recurrence and overall survival in patients of the sevoflurane and propofol group of the primary clinical trial.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Canton of Zurich
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Zurich、Canton of Zurich、瑞士、8091
- University Hospital Zurich, Institute of Anesthesiology and Perioperative Medicine
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Only patients who consented and participated in the trial CEC N° 2016 - 01791 can be enrolled.
- GC must be available for patients with follow-up consultations at USZ.
- For patients with follow-up consultations outside of the USZ for those with unknown GC status, and for those who declined the GC, a study-specific written informed consent must be obtained, which will allow the research team to contact the responsible physician
Exclusion Criteria:
- Declined study-specific informed consent
- Inability to provide study-specific consent
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 |
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Only Patient who were enrolled into the clinical trial CEC 2016 - 01791.
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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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Primary co-outcomes are defined as overall survival and disease-free survival.
大体时间：5 and 10 years after first enrollement
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A 5- and 10-year follow-up will be performed for all patients participating in the initial study.
In this follow-up, we aim to show both groups' cancer recurrence rates and survival curves 5 and 10 years after surgery.
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5 and 10 years after first enrollement
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合作者和调查者
调查人员
- 首席研究员：Martin Schläpfer, Prof. Dr. med. M.Sc.、University of Zurich
- 学习椅：Beatrice Beck Schimmer, Prof. Dr. med、University of Zurich
出版物和有用的链接
一般刊物
- Enlund M, Berglund A, Enlund A, Lundberg J, Warnberg F, Wang DX, Ekman A, Ahlstrand R, Flisberg P, Hedlund L, Ostlund I, Bergkvist L; CAN-study group. Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane. EClinicalMedicine. 2023 Jun 9;60:102037. doi: 10.1016/j.eclinm.2023.102037. eCollection 2023 Jun.
- Hovaguimian F, Braun J, Z'graggen BR, Schlapfer M, Dumrese C, Ewald C, Dedes KJ, Fink D, Rolli U, Seeberger M, Tausch C, Papassotiropoulos B, Puhan MA, Beck-Schimmer B. Anesthesia and Circulating Tumor Cells in Primary Breast Cancer Patients: A Randomized Controlled Trial. Anesthesiology. 2020 Sep;133(3):548-558. doi: 10.1097/ALN.0000000000003409.
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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