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Nordic Cystectomy Study II - Albumin

NCT04523038 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1700

Last updated 2020-11-25

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

S-Albumin

Preoperative serum albumin levels

Sponsors & Collaborators

  • Nordic Urothelial Cancer Group

    collaborator OTHER

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Peter Boström, MD, PhD · Turku University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-30
Primary Completion
2025-08-30
Completion
2025-08-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523038 on ClinicalTrials.gov