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

NCT04523025 | Unknown

• 1 other identifier: T197/2020
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Bladder-cancer specific survival

  24 months

Secondary Outcomes (2)

• Progression-free survival

  24 months

• overall survival

  24 months

Study Arms (2)

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

NLR-ratio DIAGNOSTIC_TEST

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

High NLR-ratio; Low NLR-ratio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Turku University Hospital: lead
• Nordic Urothelial Cancer Group: collaborator

Study Sites (1)

University Hospital of Turku, Hospital Distric of Southwest Finland

Turku, Southwest Finland, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Peter Boström, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Otto Ettala, MD, PhD

CONTACT

23130280; otto.ettala@tyks.fi

Ilkka Nikulainen, MD

CONTACT

23137928; ilkka.nikulainen@tyks.fi

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: August 30, 2020
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)