Actively Recruiting

Age: 18Years +
All Genders
ID07077447

DaBlaCa 23 - The European Collaborative Study on Upper Urinary Tract Urothelial Carcinoma

Led by Zealand University Hospital · Updated on 2025-12-22

2500

Participants Needed

5

Research Sites

500 weeks

Total Duration

On this page

Sponsors

Z

Zealand University Hospital

Lead Sponsor

A

Aarhus University Hospital Skejby

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates upper urinary tract urothelial carcinoma (UTUC), a rare cancer affecting the kidney's pelvis and ureter. The study focuses on comparing current treatments, particularly kidney-sparing surgery versus the standard removal of the kidney and ureter. It aims to determine if more patients with superficial, non-invasive UTUC can safely preserve their kidney without increasing cancer recurrence risk while maintaining quality of life. The study also explores bladder cancer development after UTUC treatment, kidney function changes, and outcomes for patients with Lynch syndrome, a genetic condition linked to UTUC. The study is an observational, multicenter cohort involving patients diagnosed with UTUC confirmed by pathology. It compares groups receiving kidney-sparing surgery, especially those with imperative indications, to those undergoing radical nephroureterectomy, the standard treatment. No experimental treatments are assigned; clinical care follows routine practice. Data is collected at diagnosis and during follow-ups at 1, 3, 5, and 10 years, including quality-of-life questionnaires for Danish patients. Participants provide medical record information and complete quality-of-life surveys. Researchers will assess overall survival, cancer-specific survival, recurrence rates, disease progression, kidney function over time, and patient-reported outcomes. Data is securely collected and managed, with long-term follow-up planned up to 10 years. The study supports improving personalized treatment and refining prediction tools for UTUC outcomes.

CONDITIONS

Brief Title

The Danish Bladder Cancer Group 23 Study - A European Study on Cancer in the Upper Urinary Tract

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with confirmed histopathology of UTUC
  • Age 65 18 years
  • Informed patient consent
Not Eligible

You will not qualify if you...

  • Patient not willing or able to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Enrollment

Duration - 1 day

Participants with confirmed upper urinary tract urothelial carcinoma (UTUC) are enrolled in the study.

1 enrollment visit (in-person)

Monitoring

Duration - Up to 10 years

Participants are observed following their routine clinical management for UTUC, which may include kidney sparing surgery or radical nephroureterectomy.

Follow-up visits at 1, 3, 5, and 10 years

Patient Reported Outcome Measures

Duration - Up to 5 years

Participants complete quality of life questionnaires electronically during follow-up to assess health status and well-being.

Questionnaires distributed electronically at follow-up visits

Trial Site Locations

Total: 5 locations

1

Department of Urology Aarhus University Hospital

Aarhus N, Denmark, 8200

Not Yet Recruiting

2

Herlev Gentofte Hospital

Herlev, Denmark, 2730

Not Yet Recruiting

3

Department of Urology, Copenhagen University Hospital - Rigshospitalet

København Ø, Denmark, 2100

Not Yet Recruiting

4

Department of Urology, Zealand University Hospital

Roskilde, Denmark, 4000

Actively Recruiting

5

Haukeland University Hospital

Bergen, Norway, 5009

Not Yet Recruiting

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Research Team

J

Juan L Vásquez, MD, PhD

S

Stine H Reeler, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

The utility of clinical registries for guiding clinical practice in upper tract urothelial cancer: a narrative review.

Joshua Kealey, Ruth Snider, Dickon Hayne...

https://pubmed.ncbi.nlm.nih.gov/37032753

Evaluation of Intraoperative Versus Postoperative Adjuvant Mitomycin C with Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract.

Blake Noennig, Shahab Bozorgmehri, Russell Terry...

https://pubmed.ncbi.nlm.nih.gov/30417049

Do repeated transurethral procedures under general anesthesia influence mortality in patients with non-invasive urothelial bladder cancer? A Danish national cohort study.

Marie Schmidt Erikson, Astrid Christine Petersen, Klaus Kaae Andersen...

https://pubmed.ncbi.nlm.nih.gov/32584153

A Systematic Review and Meta-analysis of Clinicopathologic Factors Linked to Intravesical Recurrence After Radical Nephroureterectomy to Treat Upper Tract Urothelial Carcinoma.

Thomas Seisen, Benjamin Granger, Pierre Colin...

https://pubmed.ncbi.nlm.nih.gov/25488681

Immunohistochemical Screening of Upper Tract Urothelial Carcinomas for Lynch Syndrome Diagnostics: A Systematic Review.

Maria Rasmussen, Mia Gebauer Madsen, Christina Therkildsen

https://pubmed.ncbi.nlm.nih.gov/35217028

Upper Tract Urothelial Carcinoma in the Lynch Syndrome Tumour Spectrum: A Comprehensive Overview from the European Association of Urology - Young Academic Urologists and the Global Society of Rare Genitourinary Tumors.

Chiara Lonati, Andrea Necchi, Juan Gómez Rivas...

https://pubmed.ncbi.nlm.nih.gov/34896051

Lynch syndrome in urological practice: diagnosis, therapeutic strategies, and screening for upper tract urothelial carcinoma.

Chiara Lonati, Marco Moschini, Claudio Simeone...

https://pubmed.ncbi.nlm.nih.gov/34608026