Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1700 participants
OBSERVATIONAL
2020-09-30
2025-09-30
Brief Summary
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The purpose of this study is to collect prospective clinical data on radical cystectomy -patients in co-operation with other Nordic countries: Sweden, Denmark, Iceland and Norway. The collected data is used to validate existing prediction tools and discover novel tools for prediction of morbidity related to RC and prediction of oncological outcome after RC. The study is divided into three sub-studies. Transfusions during RC and the time of hospitalization after the surgery are associated poorer oncological outcome when compared to those patients who do not need transfusions. The third study focuses on the oncological outcomes in patients receiving blood transfusions. As there are some conflicting reports and the finding is not properly validated, we aim to validate the effect of transfusions on survival after RC.
The number of transfusions during RC and the time between surgery and discharge from hospital will be recorded. Patient cohort will be divided into patients receiving transfusions and not receiving transfusion. The primary end point is patients receiving transfusion and its effect on cancer specific mortality at 24 months. For patients receiving NAC, additional secondary end-point is complete response (pT0N0) rate at RC.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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No transfusions
Patients receiving no perioperative blood transfusions (PBT)
Blood transfusion
Transfusion of red blood cells peri-operatively
Transfusions
Patients receiving perioperative blood transfusions (PBT)
Blood transfusion
Transfusion of red blood cells peri-operatively
Interventions
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Blood transfusion
Transfusion of red blood cells peri-operatively
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed urinary BC planned to be treated with palliative cystectomy
* Signed informed consent
* Patient age \>18 years
Exclusion Criteria
* Other forms of surgical treatment of BC than RC (e.g. bladder resection).
* Patient unwillingness to participate in the study for any reason (i.e. lack of signed consent).
18 Years
ALL
No
Sponsors
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Nordic Urothelial Cancer Group
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Peter Boström, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Locations
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University Hospital of Turku, Hospital Distric of Southwest Finland
Turku, Southwest Finland, Finland
Countries
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Central Contacts
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Facility Contacts
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Otto Ettala, MD, PhD
Role: primary
Other Identifiers
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T199/2020
Identifier Type: -
Identifier Source: org_study_id