Bladder CancerNorCys-TransfNCT04537221
Nordic Cystectomy Study III - Transfusion
An observational study of Bladder Cancer and Invasive Bladder Cancer, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Invasive Bladder Cancer
- What is being tested?
- Blood transfusion
- How many people
- 1,700 participants
- Where
- 1 siteFinland
- Study dates
- 30 Sep 2020to 30 Sep 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with muscle-invasive bladder cancer undergoing radical cystectomy -surgery
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
University Hospital of Turku, Hospital Distric of Southwest Finland
Turku, Southwest Finland, 20521
Otto Ettala, MD, PhD, 23130280 ext. +358, otto.ettala@tyks.fi
About this study
Official title: 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.
- Conditions
- Bladder Cancer, Invasive Bladder Cancer
- Being tested
- Blood transfusion
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionBiological
Transfusion of red blood cells peri-operatively
| Study group | Role | What they receive |
|---|---|---|
| No transfusions | Patients receiving no perioperative blood transfusions (PBT) Receives: Biological: Blood transfusion | |
| Transfusions | Patients receiving perioperative blood transfusions (PBT) Receives: Biological: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start30 Sep 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Nordic Urothelial Cancer Group
- Responsible party
- Sponsor
- Investigators
- Peter Boström, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537221
- Sponsor's protocol ID
- T199/2020
- Acronym
- NorCys-Transf
- Status last verified
- Nov 2020
- First submitted
- 19 Aug 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic Cystectomy Study III - Prospective Validation of Transfusions as a Poor Prognostic Factor After Radical Cystectomy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT04537221
- Acronym / sponsor ID
- NorCys-Transf / T199/2020
- Conditions
- Bladder Cancer, Invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Nordic Urothelial Cancer Group
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No transfusions | – | Biological: Blood transfusionPatients receiving no perioperative blood transfusions (PBT) |
| Transfusions | – | Biological: Blood transfusionPatients receiving perioperative blood transfusions (PBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with muscle-invasive bladder cancer undergoing radical cystectomy -surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood transfusionTransfusion of red blood cells peri-operatively | Biological | No transfusions, Transfusions |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Boström, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Invasive Bladder Cancer, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Otto Ettala, MD, PhD (23130280 ext. +358, otto.ettala@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood transfusion (PBT) effect on cancer specific mortality (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.