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| Name | Class |
|---|---|
| Nordic Urothelial Cancer Group | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low albumin | Patients presenting with low albumin levels preoperatively (<3,5 mg/l) |
| |
| Normal albumin | Patients presenting with normal or high albumin levels preoperatively (>3,5 mg/l) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-Albumin | Diagnostic Test | Preoperative serum albumin levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe complications | Complication (Clavien Dindo classes 3-5) risk after radical cystectomy for bladder cancer | 3 months |
| 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 |
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Inclusion Criteria:
2) Signed informed consent 3) Patient age >18 years
Exclusion Criteria:
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Adult patients with muscle-invasive bladder cancer undergoing radical cystectomy -surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Otto Ettala, MD, PhD | Contact | 23130280 | +358 | otto.ettala@tyks.fi |
| Ilkka Nikulainen, MD | Contact | 23137928 | +358 | ilkka.nikulainen@tyks.fi |
| Name | Affiliation | Role |
|---|---|---|
| Peter Boström, MD, PhD | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Turku, Hospital Distric of Southwest Finland | Recruiting | Turku | Southwest Finland | 20521 | Finland |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 3 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |