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NCT07077447Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 22 Dec 2025

Brief summary (registry, in English)

This is a study looking at how patients with a rare type of cancer in the pelvis and ureter of the kidney - called upper urinary tract urothelial carcinoma (UTUC) - is currently treated. The gold standard treatment of UTUC is the complete removal of the kidney, renal pelvis and ureter. The use of kidney-sparing surgery, which preserves the kidney while treating the cancer, was only considered for patients who were too frail to undergo kidney removal, had a solitary functioning kidney, or suffered from severe chronic kidney disease. Since 2018 international guidelines have incorporated kidney sparing surgery for all patients but only offered to patients that have been diagnosed with very low risk tumors to ensure the safety of the patients. The latest update of the UTUC Guidelines from the European Association of Urology has revised the criteria, so that certain features previously classified as high-risk are no longer considered high-risk on their own, provided the tumor otherwise appears benign. Nonetheless, ongoing research is essential to support this evolving approach and to further enhance the guidelines. Kidney sparing surgery comprise of a strict follow up schedule that often demands supplemental surgeries under general anesthesia, which can cause strain on patients. Preservation of the kidney is important since a decrease in kidney function can result in increased risk of cardiovascular disease and death. The main question we want to answer is: Can more patients with superficial non-invasive UTUC safely be treated with kidney-sparing surgery instead of the more aggressive surgery that removes the entire kidney and ureter without increasing the risk of the cancer coming back and while maintaining quality of life? Furthermore, we are interested in learning more about patients who later develop bladder cancer after treatment of UTUC (intravesical recurrences), the affection of kidney function over time and a subgroup of UTUC patients that are diagnosed with Lynch syndrome (a genetic condition that increases cancer risk and development of UTUC is the third most common cancer) where UTUC presents differently than other patients. Participants Anyone diagnosed with UTUC can take part in the study. We will collect information from their medical records when they join and again after one, three, five, and ten years. Participants will also be asked to fill out quality-of-life questionnaires at the beginning of entering the study and at one, three and five years.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2500 (estimated)
First submitted
13 Jul 2025
Start date
26 Nov 2025
Primary completion date
30 Nov 2030
Lead sponsor
Zealand University Hospital
NCT number
NCT07077447

What you commit to

  • Study type: Observational
  • Planned participants: 2500
  • From 26 Nov 2025 to the primary completion date, 30 Nov 2030
  • 5 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patient not willing or able to give informed consent

Who the study is looking for

  • Patients with confirmed histopathology of UTUC
  • Age ≥ 18 years
  • Informed patient consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Urology Aarhus University Hospital
Coordinator of this site? Confirm its status
Aarhus NDenmarkNot yet recruiting
Herlev & Gentofte Hospital
Coordinator of this site? Confirm its status
HerlevDenmarkNot yet recruiting
Department of Urology, Copenhagen University Hospital - Rigshospitalet
Coordinator of this site? Confirm its status
København ØDenmarkNot yet recruiting
Department of Urology, Zealand University Hospital
Coordinator of this site? Confirm its status
RoskildeDenmarkRecruiting
Haukeland University Hospital
Coordinator of this site? Confirm its status
BergenNorwayNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.