Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Urinary Tract Urothelial Carcinoma | Renal Pelvis and Ureter Urothelial Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Kidney sparing surgery for high-risk upper urinary tract urothelial carcinoma | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All patientens diagnosed with upper urinary tract urothelial carcinoma (UTUC)
- description
- The study includes all patients diagnosed with upper tract urothelial carcinoma (UTUC) confirmed by histopathology. As a cohort study, it involves no interventions.
- interventionNames
- Procedure: Kidney sparing surgery for high-risk upper urinary tract urothelial carcinoma
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From the end of enrollement until 10 years after inclusion or time of death
- description
- At each follow-up (after 1, 3, 5, and 10 years), we will record whether each participant is alive or has passed away. If a participant has died, we will register whether the cause of death was due to their upper urinary tract cancer or from another cause. This information will be entered into the electronic case report form (eCRF). By doing this, we can better understand how different treatments affect survival related specifically to the cancer.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with confirmed histopathology of UTUC * Age ≥ 18 years * Informed patient consent Exclusion Criteria: * Patient not willing or able to give informed consent
References
Publications (23)
- BACKGROUNDKealey J, Snider R, Hayne D, Davis ID, Sengupta S. The utility of clinical registries for guiding clinical practice in upper tract urothelial cancer: a narrative review. Transl Androl Urol. 2023 Mar 31;12(3):497-507. doi: 10.21037/tau-22-641. Epub 2023 Mar 16. PMID 37032753
- BACKGROUNDNoennig B, Bozorgmehri S, Terry R, Otto B, Su LM, Crispen PL. Evaluation of Intraoperative Versus Postoperative Adjuvant Mitomycin C with Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract. Bladder Cancer. 2018 Oct 29;4(4):389-394. doi: 10.3233/BLC-180174. PMID 30417049
- BACKGROUNDWang Z, Shi H, Xu Y, Fang Y, Song J, Jiang W, Xia D, Wu Z, Wang L. Intravesical Therapy for Upper Urinary Tract Urothelial Carcinoma: A Comprehensive Review. Cancers (Basel). 2023 Oct 17;15(20):5020. doi: 10.3390/cancers15205020. PMID 37894387
- BACKGROUNDErikson MS, Petersen AC, Andersen KK, Jacobsen FK, Mogensen K, Hermann GG. Do repeated transurethral procedures under general anesthesia influence mortality in patients with non-invasive urothelial bladder cancer? A Danish national cohort study. Scand J Urol. 2020 Aug;54(4):281-289. doi: 10.1080/21681805.2020.1782978. Epub 2020 Jun 25. PMID 32584153
- BACKGROUNDSeisen T, Granger B, Colin P, Leon P, Utard G, Renard-Penna R, Comperat E, Mozer P, Cussenot O, Shariat SF, Roupret M. A Systematic Review and Meta-analysis of Clinicopathologic Factors Linked to Intravesical Recurrence After Radical Nephroureterectomy to Treat Upper Tract Urothelial Carcinoma. Eur Urol. 2015 Jun;67(6):1122-1133. doi: 10.1016/j.eururo.2014.11.035. Epub 2014 Dec 6. PMID 25488681
- BACKGROUNDRaman JD, Ng CK, Boorjian SA, Vaughan ED Jr, Sosa RE, Scherr DS. Bladder cancer after managing upper urinary tract transitional cell carcinoma: predictive factors and pathology. BJU Int. 2005 Nov;96(7):1031-5. doi: 10.1111/j.1464-410X.2005.05804.x. PMID 16225523