Nordic Cystectomy Study II - Albumin (NorCys-Alb)

Nordic Cystectomy Study II - Low Preoperative Albumin Levels Predicting Postoperative Complications in Radical Cystectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Invasive Bladder Cancer
• Intervention / Treatment: Diagnostic test: S-Albumin

• Study Type: Observational
• Enrollment (Anticipated): 1700

Contacts and Locations

Study Locations

• Finland
  • 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: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low albumin; Patients presenting with low albumin levels preoperatively (<3,5 mg/l)	Diagnostic test: S-Albumin; Preoperative serum albumin levels
Normal albumin; Patients presenting with normal or high albumin levels preoperatively (>3,5 mg/l)	Diagnostic test: S-Albumin; Preoperative serum albumin levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe complications	Complication (Clavien Dindo classes 3-5) risk after radical cystectomy for bladder cancer	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All complications	Complication (Clavien Dindo classes 1-5) risk after radical cystectomy for bladder cancer	3 months
Mortality	Complication (Clavien Dindo 5) risk after radical cystectomy for bladder cancer	3 months

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Nordic Urothelial Cancer Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2020
• Primary Completion (ANTICIPATED): August 30, 2025
• Study Completion (ANTICIPATED): August 30, 2025

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (ACTUAL): August 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: T198/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No