Bladder CancerNorCys-AlbNCT04523038
Nordic Cystectomy Study II - Albumin
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?
- S-Albumin
- How many people
- 1,700 participants
- Where
- 1 siteFinland
- Study dates
- 30 Aug 2020to 30 Aug 2025
- How long will I take part?
- 3 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
- 2) Signed informed consent 3) 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 II - Low Preoperative Albumin Levels Predicting Postoperative Complications in Radical Cystectomy
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. The first sub-study is to validate low albumin levels as a predictor of complications after RC . The cut-off for low albumin has been <3,5 mg/l across the studies. This could be a very cost-effective biomarker but currently its relevance is limited by lack of proper prospective validation studies.
The primary end-point in the Albumin sub-study is the 90-day major (Clavien Dindo 3-5) complication rate. The secondary end-points include total 90-day complication (Clavien 1-5) and 90-mortality rate (Clavien 5) for all patients and complication rate during NAC for patients receiving chemotherapy.
- Conditions
- Bladder Cancer, Invasive Bladder Cancer
- Being tested
- S-Albumin
- 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.
S-AlbuminDiagnostic test
Preoperative serum albumin levels
| Study group | Role | What they receive |
|---|---|---|
| Low albumin | Patients presenting with low albumin levels preoperatively (<3,5 mg/l) Receives: Diagnostic Test: S-Albumin | |
| Normal albumin | Patients presenting with normal or high albumin levels preoperatively (>3,5 mg/l) Receives: Diagnostic Test: S-Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe complications
Complication (Clavien Dindo classes 3-5) risk after radical cystectomy for bladder cancer
Measured: 3 months
Secondary outcomes (2)
All complications
Complication (Clavien Dindo classes 1-5) risk after radical cystectomy for bladder cancer
Measured: 3 months
Mortality
Complication (Clavien Dindo 5) risk after radical cystectomy for bladder cancer
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start30 Aug 2020
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 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
- 3 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
- NCT04523038
- Sponsor's protocol ID
- T198/2020
- Acronym
- NorCys-Alb
- 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 II - Low Preoperative Albumin Levels Predicting Postoperative Complications in Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04523038
- Acronym / sponsor ID
- NorCys-Alb / T198/2020
- 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 Aug 2020 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 21 Aug 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. The first sub-study is to validate low albumin levels as a predictor of complications after RC . The cut-off for low albumin has been <3,5 mg/l across the studies. This could be a very cost-effective biomarker but currently its relevance is limited by lack of proper prospective validation studies.
The primary end-point in the Albumin sub-study is the 90-day major (Clavien Dindo 3-5) complication rate. The secondary end-points include total 90-day complication (Clavien 1-5) and 90-mortality rate (Clavien 5) for all patients and complication rate during NAC for patients receiving chemotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low albumin | – | Diagnostic Test: S-AlbuminPatients presenting with low albumin levels preoperatively (<3,5 mg/l) |
| Normal albumin | – | Diagnostic Test: S-AlbuminPatients presenting with normal or high albumin levels preoperatively (>3,5 mg/l) |
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 (3 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
- 2) Signed informed consent 3) 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 |
|---|---|---|
| S-AlbuminPreoperative serum albumin levels | Diagnostic test | Low albumin, Normal albumin |
Primary outcome
Severe complications
Time frame: 3 months
Complication (Clavien Dindo classes 3-5) risk after radical cystectomy for bladder cancer
2 secondary outcomes
All complications
Time frame: 3 months
Mortality
Time frame: 3 months
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
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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 3 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?
Severe complications (time frame: 3 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.