- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07689253
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)
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Canton of Zurich
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Zurich, Canton of Zurich, Switzerland, 8091
- University Hospital Zurich, Institute of Anesthesiology and Perioperative Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Only Patient who were enrolled into the clinical trial CEC 2016 - 01791.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Primary co-outcomes are defined as overall survival and disease-free survival.
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Schläpfer, Prof. Dr. med. M.Sc., University of Zurich
- Study Chair: Beatrice Beck Schimmer, Prof. Dr. med, University of Zurich
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025 - 00668
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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