Bladder CancerNorCys-NLRNCT04523025
Nordic Cystectomy Study I - Neutrophil-lymphocyte Ratio (NLR)
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?
- NLR-ratio
- How many people
- 230 participants
- Where
- 1 siteFinland
- Study dates
- 30 Aug 2020to 30 Aug 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 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 I - Prospective Validation of Neutrophil/Lymphocyte Ratio as Predictor of Bladder Cancer Survival Risk 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. The second sub-study is on the preoperative neutrophil-lymphocyte ratio (NLR). Some studies suggest that NLR might be a predictor of oncological outcome of BC after RC. In addition, NLR has been suggested to correlate with NAC response and outcome after NAC and RC. The used cut-off value for NLR has varied between 2.26-3.0.
Patients will be allocated into two groups: low NLR ratio (NLR<3), and high NLR ratio (NLR≥3). The lab test will be retrieved before RC at the time of routine clinical laboratory testing for all patients and also before the initiation of NAC for patients planned to have chemotherapy. The primary end-point is bladder-cancer specific survival and, and secondary endpoints include progression-free, and overall survival.
- Conditions
- Bladder Cancer, Invasive Bladder Cancer
- Being tested
- NLR-ratio
- 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.
NLR-ratioDiagnostic test
The ratio of neutrophils and lymphocytes in patients blood sample prior to surgical operation
| Study group | Role | What they receive |
|---|---|---|
| Low NLR-ratio | Patients with low NLR ratio (NLR<3) Receives: Diagnostic Test: NLR-ratio | |
| High NLR-ratio | Patients with high NLR ratio (NLR≥3) Receives: Diagnostic Test: NLR-ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder-cancer specific survival
Measured: 24 months
Secondary outcomes (2)
Progression-free survival
Measured: 24 months
overall survival
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 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.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- 230 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
- NCT04523025
- Sponsor's protocol ID
- T197/2020
- Acronym
- NorCys-NLR
- 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 I - Prospective Validation of Neutrophil/Lymphocyte Ratio as Predictor of Bladder Cancer Survival Risk After Radical Cystectomy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT04523025
- Acronym / sponsor ID
- NorCys-NLR / T197/2020
- Conditions
- Bladder Cancer, Invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 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 second sub-study is on the preoperative neutrophil-lymphocyte ratio (NLR). Some studies suggest that NLR might be a predictor of oncological outcome of BC after RC. In addition, NLR has been suggested to correlate with NAC response and outcome after NAC and RC. The used cut-off value for NLR has varied between 2.26-3.0.
Patients will be allocated into two groups: low NLR ratio (NLR<3), and high NLR ratio (NLR≥3). The lab test will be retrieved before RC at the time of routine clinical laboratory testing for all patients and also before the initiation of NAC for patients planned to have chemotherapy. The primary end-point is bladder-cancer specific survival and, and secondary endpoints include progression-free, and overall survival.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low NLR-ratio | – | Diagnostic Test: NLR-ratioPatients with low NLR ratio (NLR<3) |
| High NLR-ratio | – | Diagnostic Test: NLR-ratioPatients with high NLR ratio (NLR≥3) |
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 (2 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 |
|---|---|---|
| NLR-ratioThe ratio of neutrophils and lymphocytes in patients blood sample prior to surgical operation | Diagnostic test | High NLR-ratio, Low NLR-ratio |
Primary outcome
Bladder-cancer specific survival
Time frame: 24 months
2 secondary outcomes
Progression-free survival
Time frame: 24 months
overall survival
Time frame: 24 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 2 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?
Bladder-cancer specific survival (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.