Observational study on albumin in bladder cancer treatment
Nordic Cystectomy Study II - Low Preoperative Albumin Levels Predicting Postoperative Complications in Radical Cystectomy
This study is testing how S-Albumin levels can help doctors understand the risks and treatment outcomes for patients with muscle invasive bladder cancer who are having surgery, with or without chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Turku, Southwest Finland) |
| Trial ID | NCT04523038 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with muscle invasive bladder cancer who are planned to undergo radical cystectomy, with or without neoadjuvant chemotherapy. It aims to assess the role of S-Albumin in the treatment process, particularly in evaluating individual risk assessments and prognosis for patients. The study will include around 7200 cases from the Nordic countries, providing valuable insights into treatment outcomes and the effectiveness of chemotherapy in this aggressive disease. By analyzing patient responses and recovery, the study seeks to improve treatment planning and patient management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with histologically confirmed urinary bladder cancer scheduled for radical cystectomy.
Not a fit: Patients undergoing radical cystectomy for reasons other than bladder cancer or those unwilling to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies and improve outcomes for patients with muscle invasive bladder cancer.
How similar studies have performed: While there have been studies on neoadjuvant chemotherapy in bladder cancer, the specific focus on S-Albumin in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Turku, Southwest Finland
- University Hospital of Turku, Hospital Distric of Southwest Finland — Turku, Southwest Finland, Finland (Recruiting)
Study contacts
- Principal investigator: Peter Boström, MD, PhD — Turku University Hospital
- Study coordinator: Otto Ettala, MD, PhD
- Email: otto.ettala@tyks.fi
- Phone: 23130280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.