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| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
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Goal of this observational study is to analyze data about cancer recurrence rates 5 and 10 years after primary breast cancer surgery with propofol or sevoflurane anesthesia. Only patients who were enrolled in the primary interventional trial can participate.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only Patient who were enrolled into the clinical trial CEC 2016 - 01791. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary co-outcomes are defined as overall survival and disease-free survival. | 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. | 5 and 10 years after first enrollement |
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Inclusion Criteria:
Exclusion Criteria:
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Only patients who participated in the clinical trial (CEC 2016 - 01791) can be included into this study.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schläpfer, Prof. Dr. med. M.Sc. | University of Zurich | Principal Investigator |
| Beatrice Beck Schimmer, Prof. Dr. med | University of Zurich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Institute of Anesthesiology and Perioperative Medicine | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37333664 | Background | 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. | |
| 32568845 |
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It is not yet known if there will be a plan to make IPD available.
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| Background |
| 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. |
| ID | Term |
|---|---|
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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