Nordic Cystectomy Study I - Neutrophil-lymphocyte Ratio (NLR)
NCT ID: NCT04523025
Last Updated: 2020-11-25
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
230 participants
OBSERVATIONAL
2020-08-30
2025-08-30
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. The second sub-study is on the preoperative neutrophil-lymphocyte ratio (NLR). Some studies suggest that NLR might be a predictor of oncological outcome of BC after RC. In addition, NLR has been suggested to correlate with NAC response and outcome after NAC and RC. The used cut-off value for NLR has varied between 2.26-3.0.
Patients will be allocated into two groups: low NLR ratio (NLR\<3), and high NLR ratio (NLR≥3). The lab test will be retrieved before RC at the time of routine clinical laboratory testing for all patients and also before the initiation of NAC for patients planned to have chemotherapy. The primary end-point is bladder-cancer specific survival and, and secondary endpoints include progression-free, and overall survival.
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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Low NLR-ratio
Patients with low NLR ratio (NLR\<3)
NLR-ratio
The ratio of neutrophils and lymphocytes in patients blood sample prior to surgical operation
High NLR-ratio
Patients with high NLR ratio (NLR≥3)
NLR-ratio
The ratio of neutrophils and lymphocytes in patients blood sample prior to surgical operation
Interventions
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NLR-ratio
The ratio of neutrophils and lymphocytes in patients blood sample prior to surgical operation
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed urinary BC planned to be treated with palliative cystectomy 2) Signed informed consent 3) Patient age \>18 years
Exclusion Criteria
2. Other forms of surgical treatment of BC than RC (e.g. bladder resection).
3. 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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T197/2020
Identifier Type: -
Identifier Source: org_study_id