Nordic Cystectomy Study III - Transfusion (NorCys-Transf)

• ClinicalTrials.gov Identifier: NCT04537221
• Recruitment Status: Recruiting
• First Posted: September 3, 2020
• Last Update Posted: November 25, 2020
• Sponsor: Turku University Hospital
• Collaborator: Nordic Urothelial Cancer Group
• Information provided by (Responsible Party): Turku University Hospital

Study Description

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. 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.

Condition or disease	Intervention/treatment
Bladder Cancer; Invasive Bladder Cancer	Biological: Blood transfusion

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 1700 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• Official Title: Nordic Cystectomy Study III - Prospective Validation of Transfusions as a Poor Prognostic Factor After Radical Cystectomy for Bladder Cancer
• Actual Study Start Date: September 30, 2020
• Estimated Primary Completion Date: September 30, 2025
• Estimated Study Completion Date: September 30, 2025

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Perioperative blood transfusion (PBT) effect on cancer specific mortality [ Time Frame: 24 months ]
   Comparison of cancer-specific-mortality between patients receiving one or more PBT perioperatively vs. patients receiving none

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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).

Contacts and Locations

Contacts

Contact: Otto Ettala, MD, PhD; 23130280 ext +358; otto.ettala@tyks.fi

Contact: Ilkka Nikulainen, MD; 23137928 ext +358; ilkka.nikulainen@tyks.fi

Locations

Finland

University Hospital of Turku, Hospital Distric of Southwest Finland; Recruiting

Turku, Southwest Finland, Finland, 20521

Contact: Otto Ettala, MD, PhD 23130280 ext +358 otto.ettala@tyks.fi

Sponsors and Collaborators

Turku University Hospital

Nordic Urothelial Cancer Group

Investigators

• Principal Investigator: Peter Boström, MD, PhD; Turku University Hospital

More Information

• Responsible Party: Turku University Hospital
• ClinicalTrials.gov Identifier: NCT04537221
• Other Study ID Numbers: T199/2020
• First Posted: September 3, 2020
• Last Update Posted: November 25, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases