Nordic Cystectomy Study III - Transfusion (NorCys-Transf)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Invasive Bladder Cancer
• Intervention / Treatment: Biological: Blood transfusion

• 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:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No transfusions; Patients receiving no perioperative blood transfusions (PBT)	Biological: Blood transfusion; Transfusion of red blood cells peri-operatively
Transfusions; Patients receiving perioperative blood transfusions (PBT)	Biological: Blood transfusion; Transfusion of red blood cells peri-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (ACTUAL): September 3, 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: T199/2020

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