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RecruitingNCT04523025NorCys-NLRUpdated Nov 25, 2020

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

An observational study in Bladder Cancer and Invasive Bladder Cancer, sponsored by Turku University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-25.

Sponsored by Turku University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Aug 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
230
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bladder Cancer
  • Invasive Bladder Cancer
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 230 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with muscle-invasive bladder cancer undergoing radical cystectomy -surgery

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

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).
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
230 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • Low NLR-ratio

    Patients with low NLR ratio (NLR\<3)

    Diagnostic Test: NLR-ratio

  • High NLR-ratio

    Patients with high NLR ratio (NLR≥3)

    Diagnostic Test: NLR-ratio

Interventions

  • Diagnostic testNLR-ratio

    The ratio of neutrophils and lymphocytes in patients blood sample prior to surgical operation

06

What researchers measure

Primary outcomes

  1. Bladder-cancer specific survival

    Time frame: 24 months

Secondary outcomes

  1. Progression-free survival

    Time frame: 24 months

  2. overall survival

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • University Hospital of Turku, Hospital Distric of Southwest Finland
    Turku, Southwest Finland 20521, Finland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04523025
Lead sponsor
Turku University Hospital
Collaborators
Nordic Urothelial Cancer Group
Responsible party
Sponsor
First posted
Aug 21, 2020
Start date
Aug 30, 2020
Primary completion
Aug 30, 2025 (estimated)
Completion
Aug 30, 2025 (estimated)
Last update
Nov 25, 2020

Study contacts

Otto Ettala, MD, PhD
Contact
otto.ettala@tyks.fi
23130280 ext. +358
Ilkka Nikulainen, MD
Contact
ilkka.nikulainen@tyks.fi
23137928 ext. +358
Peter Boström, MD, PhD
principal investigator · Turku University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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