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Nordic Cystectomy Study II - Albumin

NCT ID: NCT04523038

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-30

Study Completion Date

2025-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer Invasive Bladder Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Low albumin

Patients presenting with low albumin levels preoperatively (\<3,5 mg/l)

S-Albumin

Intervention Type DIAGNOSTIC_TEST

Preoperative serum albumin levels

Normal albumin

Patients presenting with normal or high albumin levels preoperatively (\>3,5 mg/l)

S-Albumin

Intervention Type DIAGNOSTIC_TEST

Preoperative serum albumin levels

Interventions

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S-Albumin

Preoperative serum albumin levels

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordic Urothelial Cancer Group

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Boström, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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University Hospital of Turku, Hospital Distric of Southwest Finland

Turku, Southwest Finland, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Otto Ettala, MD, PhD

Role: CONTACT

Phone: 23130280

Email: [email protected]

Ilkka Nikulainen, MD

Role: CONTACT

Phone: 23137928

Email: [email protected]

Facility Contacts

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Otto Ettala, MD, PhD

Role: primary

Other Identifiers

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T198/2020

Identifier Type: -

Identifier Source: org_study_id