Nordic Cystectomy Study III - Transfusion

Bladder Cancer Clinical Trial

— NorCys-Transf  

Official title:

Nordic Cystectomy Study III - Prospective Validation of Transfusions as a Poor Prognostic Factor After Radical Cystectomy for Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537221
• Other study ID #: T199/2020
• Status: Recruiting
• Start date: September 30, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2020
• Source: Turku University Hospital
• Contact: Otto Ettala, MD, PhD
• Phone: 23130280
• Email: otto.ettala[@]tyks.fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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. Transfusions during RC and the time of hospitalization after the surgery are associated poorer oncological outcome when compared to those patients who do not need transfusions. The third study focuses on the oncological outcomes in patients receiving blood transfusions. As there are some conflicting reports and the finding is not properly validated, we aim to validate the effect of transfusions on survival after RC.

The number of transfusions during RC and the time between surgery and discharge from hospital will be recorded. Patient cohort will be divided into patients receiving transfusions and not receiving transfusion. The primary end point is patients receiving transfusion and its effect on cancer specific mortality at 24 months. For patients receiving NAC, additional secondary end-point is complete response (pT0N0) rate at RC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1700
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Signed informed consent

• Patient age >18 years

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Bladder Cancer
• Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• Blood transfusion
Transfusion of red blood cells peri-operatively

Locations

Country	Name	City	State
Finland	University Hospital of Turku, Hospital Distric of Southwest Finland	Turku	Southwest Finland

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Nordic Urothelial Cancer Group

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative blood transfusion (PBT) effect on cancer specific mortality	Comparison of cancer-specific-mortality between patients receiving one or more PBT perioperatively vs. patients receiving none	24 months