Clinical trial NCT04523038: Nordic Cystectomy Study II - Albumin
Official title: Nordic Cystectomy Study II - Low Preoperative Albumin Levels Predicting Postoperative Complications in Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Invasive Bladder Cancer
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Nordic Urothelial Cancer Group
First posted: 2020-08-21
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with muscle-invasive bladder cancer undergoing radical cystectomy -surgery

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Severe complications
timeFrame: 3 months
Secondary outcomes:
measure: All complications
timeFrame: 3 months
measure: Mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University Hospital of Turku, Hospital Distric of Southwest Finland
state: Southwest Finland
Study officials:
affiliation: Turku University Hospital
name: Peter Boström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: