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Trial record 2 of 3 for:    norcys | Bladder Cancer

Nordic Cystectomy Study III - Transfusion (NorCys-Transf)

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

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

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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

Resource links provided by the National Library of Medicine


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




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



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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537221


Contacts
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Contact: Otto Ettala, MD, PhD 23130280 ext +358 otto.ettala@tyks.fi
Contact: Ilkka Nikulainen, MD 23137928 ext +358 ilkka.nikulainen@tyks.fi

Locations
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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
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Principal Investigator: Peter Boström, MD, PhD Turku University Hospital
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT04537221    
Other Study ID Numbers: T199/2020
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases