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Trial record 3 of 3 for:    norcys | Bladder Cancer
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Nordic Cystectomy Study II - Albumin (NorCys-Alb)

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ClinicalTrials.gov Identifier: NCT04523038
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
Nordic Urothelial Cancer Group
Information provided by (Responsible Party):
Turku University Hospital

Study Description
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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. 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.


Condition or disease Intervention/treatment
Bladder Cancer Invasive Bladder Cancer Diagnostic Test: S-Albumin

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1700 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Nordic Cystectomy Study II - Low Preoperative Albumin Levels Predicting Postoperative Complications in Radical Cystectomy
Actual Study Start Date : August 30, 2020
Estimated Primary Completion Date : August 30, 2025
Estimated Study Completion Date : August 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Low albumin
Patients presenting with low albumin levels preoperatively (<3,5 mg/l)
 Diagnostic Test: S-Albumin
Preoperative serum albumin levels
Normal albumin
Patients presenting with normal or high albumin levels preoperatively (>3,5 mg/l)
 Diagnostic Test: S-Albumin
Preoperative serum albumin levels


Outcome Measures
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Primary Outcome Measures :
  1. Severe complications [ Time Frame: 3 months ]
    Complication (Clavien Dindo classes 3-5) risk after radical cystectomy for bladder cancer


Secondary Outcome Measures :
  1. All complications [ Time Frame: 3 months ]
    Complication (Clavien Dindo classes 1-5) risk after radical cystectomy for bladder cancer

  2. Mortality [ Time Frame: 3 months ]
    Complication (Clavien Dindo 5) risk after radical cystectomy for bladder cancer


Eligibility Criteria
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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:

  1. Histologically confirmed urinary BC planned to be treated with RC with or without neoadjuvant chemotherapy.
  2. Histologically confirmed urinary BC planned to be treated with palliative cystectomy

2) Signed informed consent 3) Patient age >18 years

Exclusion Criteria:

  1. RC for other reasons than BC
  2. Other forms of surgical treatment of BC than RC (e.g. bladder resection).
  3. Patient unwillingness to participate in the study for any reason (i.e. lack of signed consent).
Contacts and Locations
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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): NCT04523038


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
More Information
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT04523038    
Other Study ID Numbers: T198/2020
First Posted: August 21, 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