Nordic Cystectomy Study I - Neutrophil-lymphocyte Ratio (NLR)

Recruiting

• Conditions: Bladder Cancer; Invasive Bladder Cancer
• Interventions: Diagnostic Test: NLR-ratio

• Registration Number: NCT04523025
• Lead Sponsor: Turku University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-21
• Study Start: 2020-08-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-25
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. Histologically confirmed urinary BC planned to be treated with RC with or without neoadjuvant chemotherapy.
2. Histologically confirmed urinary BC planned to be treated with palliative cystectomy 2) Signed informed consent 3) Patient age >18 years

Exclusion Criteria

1. RC for other reasons than BC
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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High NLR-ratio	NLR-ratio	Patients with high NLR ratio (NLR≥3)
Low NLR-ratio	NLR-ratio	Patients with low NLR ratio (NLR\<3)

Primary Outcome Measures

Name	Time	Method
Bladder-cancer specific survival	24 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	24 months
overall survival	24 months

Trial Locations

Locations (1)

University Hospital of Turku, Hospital Distric of Southwest Finland; 🇫🇮 Turku, Southwest Finland, Finland