Nordic Cystectomy Study II - Albumin

Recruiting

• Conditions: Invasive Bladder Cancer; Bladder Cancer
• Interventions: Diagnostic Test: S-Albumin

• Registration Number: NCT04523038
• 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 first sub-study is to validate low albumin levels as a predictor of complications after RC . The cut-off for low albumin has been \<3,5 mg/l across the studies. This could be a very cost-effective biomarker but currently its relevance is limited by lack of proper prospective validation studies.

The primary end-point in the Albumin sub-study is the 90-day major (Clavien Dindo 3-5) complication rate. The secondary end-points include total 90-day complication (Clavien 1-5) and 90-mortality rate (Clavien 5) for all patients and complication rate during NAC for patients receiving chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• 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: 1700

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
Low albumin	S-Albumin	Patients presenting with low albumin levels preoperatively (\<3,5 mg/l)
Normal albumin	S-Albumin	Patients presenting with normal or high albumin levels preoperatively (\>3,5 mg/l)

Primary Outcome Measures

Name	Time	Method
Severe complications	3 months	Complication (Clavien Dindo classes 3-5) risk after radical cystectomy for bladder cancer

Secondary Outcome Measures

Name	Time	Method
All complications	3 months	Complication (Clavien Dindo classes 1-5) risk after radical cystectomy for bladder cancer
Mortality	3 months	Complication (Clavien Dindo 5) risk after radical cystectomy for bladder cancer

Trial Locations

Locations (1)

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