- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523025
Nordic Cystectomy Study I - Neutrophil-lymphocyte Ratio (NLR) (NorCys-NLR)
Nordic Cystectomy Study I - Prospective Validation of Neutrophil/Lymphocyte Ratio as Predictor of Bladder Cancer Survival Risk After Radical Cystectomy for Bladder Cancer
Around 7200 cases of Muscle Invasive Bladder Cancer are diagnosed annually in the Nordic countries combined. Muscle Invasive Bladder Cancer is an aggressive disease and it is linked with high mortality rates. The golden standard of treatment is radical cystectomy (RC) (the surgical removal of the bladder) and radical removal of lymph nodes in the pelvis. In addition to surgical treatment, and especially in cases where the tumour invades tissues surrounding the bladder or lymph nodes, chemotherapy is recommended. Chemotherapy can be administered before or after surgery, in a neoadjuvant (NAC) or adjuvant setting (AC). Although most patients recover well from surgery, there are significant risks regarding radical cystectomy. The greatest challenges in planning the treatment are making individual risk assessments and prognosis for the treated patients. Neoadjuvant chemotherapy is also insufficiently used and it is hard to predict how the tumour responds to chemotherapy.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Southwest Finland
-
Turku, Southwest Finland, Finland, 20521
- Recruiting
- University Hospital of Turku, Hospital Distric of Southwest Finland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Histologically confirmed urinary BC planned to be treated with RC with or without neoadjuvant chemotherapy.
- Histologically confirmed urinary BC planned to be treated with palliative cystectomy 2) Signed informed consent 3) Patient age >18 years
Exclusion Criteria:
- RC for other reasons than BC
- 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).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Low NLR-ratio
Patients with low NLR ratio (NLR<3)
|
The ratio of neutrophils and lymphocytes in patients blood sample prior to surgical operation
|
High NLR-ratio
Patients with high NLR ratio (NLR≥3)
|
The ratio of neutrophils and lymphocytes in patients blood sample prior to surgical operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bladder-cancer specific survival
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 24 months
|
24 months
|
Progression-free survival
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- T197/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Bladder Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage III Bladder Cancer | No Evidence of Disease | Stage II Bladder Cancer | Stage IVA Bladder Cancer | Stage IVB Bladder CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteCompletedMuscle-Invasive Bladder Carcinoma | Bladder Cancer Stage II | Bladder Cancer Stage III | Bladder Cancer Stage IVUnited States
-
National Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
-
National Cancer Institute (NCI)TerminatedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Bladder Adenocarcinoma | Bladder Squamous Cell Carcinoma | Bladder Urothelial Carcinoma | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Cancer | Urinary Complications | Stage 0 Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder Cancer
-
Fox Chase Cancer CenterTerminatedStage III Bladder Cancer | Distal Urethral Cancer | Proximal Urethral Cancer | Squamous Cell Carcinoma of the Bladder | Urethral Cancer Associated With Invasive Bladder Cancer | Stage II Bladder CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Stage II Bladder CancerUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Bristol-Myers SquibbRecruitingUrinary Bladder Cancer | Invasive Bladder CancerNetherlands
-
Baylor College of MedicinePfizerTerminatedBladder Cancer | Invasive Bladder Cancer | Metastatic Bladder CancerUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Bladder Cancer | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional Cell Carcinoma of the Bladder | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
Clinical Trials on NLR-ratio
-
Assiut UniversityCompletedCopd | COPD ExacerbationEgypt
-
Universitas Sumatera UtaraCompletedBrain TumorIndonesia
-
Sohag UniversityCompleted
-
Sohag UniversityNot yet recruitingHepatocellular Carcinoma
-
Assiut UniversityNot yet recruiting
-
Fundación de Investigación Biomédica - Hospital...Not yet recruiting
-
University of ThessalyLarissa University Hospital; University Hospital, IoanninaRecruitingNeurocognitive Disorders | Neutrophil-Lymphocyte Ratio | Platelet-Lymphocyte RatioGreece
-
Hisar Intercontinental HospitalCompletedProstate Cancer | Prostate Disease | Prostate InfectionTurkey
-
University of ThessalyCompletedInflammation in EVARGreece
-
Gangnam Severance HospitalCompletedBlood Loss, SurgicalKorea, Republic of