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

NCT07077447 | Recruiting

• 2 other identifiers: SJ-1085p-2024-17586
• Study Type: observational
• Target: 2,500
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Upper Urinary Tract Urothelial Carcinoma

Keywords

UTUC; Upper Urinary Tract Urothelial Carcinoma; Kidney Sparing Surgery; Prospective cohort study; Ureteroscopy; Radical nephroureterectomy; Lynch Syndrome; Endoscopic management of UTUC

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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.

  From the end of enrollement until 10 years after inclusion or time of death

Secondary Outcomes (5)

• Cancer specific survival

  From the end of enrollement until 10 years after inclusion or time of death

• Recurrences

  From enrollement until five years either after diagnosis or last recurrence according to current follow up guidelines.

• Progression

  From enrollment until five years of follow up

• Renal function

  from enrollment until ten years

• Patient reported outcome measures

  Enrollment until five years or death.

Study Arms (1)

All patientens diagnosed with upper urinary tract urothelial carcinoma (UTUC)

The study includes all patients diagnosed with upper tract urothelial carcinoma (UTUC) confirmed by histopathology. As a cohort study, it involves no interventions.

Procedure: Kidney sparing surgery for high-risk upper urinary tract urothelial carcinoma

Interventions

Kidney sparing surgery for high-risk upper urinary tract urothelial carcinoma PROCEDURE

This is an observational cohort study with no direct intervention assigned by the investigators. The study compares two groups of patients in our cohort diagnosed with high-risk pTa upper tract urothelial carcinoma (UTUC), as defined by the European Association of Urology (EAU) guidelines. The "experimental" group includes patients who, due to imperative indications (e.g., solitary kidney, impaired renal function, or comorbidities), undergo kidney-sparing surgery. These patients are compared to a reference group treated with radical nephroureterectomy, which is considered "standard of care".

All patientens diagnosed with upper urinary tract urothelial carcinoma (UTUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with UTUC on a histopatohological specimen from departments of urology within Europe and the USA.

You may qualify if:

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

You may not qualify if:

• Patient not willing or able to give informed consent

Sponsors & Collaborators

• Zealand University Hospital: lead
• Aarhus University Hospital Skejby: collaborator
• Rigshospitalet, Denmark: collaborator
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (5)

Department of Urology Aarhus University Hospital

Aarhus N, 8200, Denmark

NOT YET RECRUITING

Herlev Gentofte Hospital

Herlev, 2730, Denmark

NOT YET RECRUITING

Department of Urology, Copenhagen University Hospital - Rigshospitalet

København Ø, 2100, Denmark

NOT YET RECRUITING

Department of Urology, Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

Haukeland University Hospital

Bergen, 5009, Norway

NOT YET RECRUITING

Related Publications (23)

• Kealey 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 BACKGROUND

• Noennig 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 BACKGROUND

• Wang 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 BACKGROUND

• Erikson 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 BACKGROUND

• Seisen 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 BACKGROUND

• Raman 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 BACKGROUND

• Lim A, Rao P, Matin SF. Lynch syndrome and urologic malignancies: a contemporary review. Curr Opin Urol. 2019 Jul;29(4):357-363. doi: 10.1097/MOU.0000000000000639.

  PMID: 31045926 BACKGROUND

• Rasmussen M, Madsen MG, Therkildsen C. Immunohistochemical Screening of Upper Tract Urothelial Carcinomas for Lynch Syndrome Diagnostics: A Systematic Review. Urology. 2022 Jul;165:44-53. doi: 10.1016/j.urology.2022.02.006. Epub 2022 Feb 22.

  PMID: 35217028 BACKGROUND

• Lonati C, Necchi A, Gomez Rivas J, Afferi L, Laukhtina E, Martini A, Ventimiglia E, Colombo R, Gandaglia G, Salonia A, Briganti A, Montorsi F, Mattei A, Simeone C, Carlo MI, Shariat SF, Spiess PE, Moschini M; European Association of Urology Young Academic Urologists EAU-YAU: Urothelial Carcinoma Working Group, the Global Society of Rare Genitourinary Tumors GSRGT. 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. Eur Urol Oncol. 2022 Feb;5(1):30-41. doi: 10.1016/j.euo.2021.11.001. Epub 2021 Dec 9.

  PMID: 34896051 BACKGROUND

• Lonati C, Moschini M, Simeone C, Spiess PE, Necchi A. Lynch syndrome in urological practice: diagnosis, therapeutic strategies, and screening for upper tract urothelial carcinoma. Curr Opin Urol. 2022 Jan 1;32(1):40-47. doi: 10.1097/MOU.0000000000000936.

  PMID: 34608026 BACKGROUND

• Tonelli M, Wiebe N, Culleton B, House A, Rabbat C, Fok M, McAlister F, Garg AX. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006 Jul;17(7):2034-47. doi: 10.1681/ASN.2005101085. Epub 2006 May 31.

  PMID: 16738019 BACKGROUND

• Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.

  PMID: 27887750 BACKGROUND

• Tafuri A, Marchioni M, Cerrato C, Mari A, Tellini R, Odorizzi K, Veccia A, Amparore D, Shakir A, Carbonara U, Panunzio A, Trovato F, Catellani M, Janello LMI, Bianchi L, Novara G, Dal Moro F, Schiavina R, De Lorenzis E, Parma P, Cimino S, De Cobelli O, Maiorino F, Bove P, Crocerossa F, Cantiello F, D'Andrea D, Di Cosmo F, Porpiglia F, Ditonno P, Montanari E, Soria F, Gontero P, Liguori G, Trombetta C, Mantica G, Borghesi M, Terrone C, Del Giudice F, Sciarra A, Galosi A, Moschini M, Shariat SF, Di Nicola M, Minervini A, Ferro M, Cerruto MA, Schips L, Pagliarulo V, Antonelli A. Changes in renal function after nephroureterectomy for upper urinary tract carcinoma: analysis of a large multicenter cohort (Radical Nephroureterectomy Outcomes (RaNeO) Research Consortium). World J Urol. 2022 Nov;40(11):2771-2779. doi: 10.1007/s00345-022-04156-3. Epub 2022 Oct 6.

  PMID: 36203101 BACKGROUND

• Hasan MN, Roupret M, Keeley F, Cracco C, Jones R, Straub M, Traxer O, Osther PJS, Brehmer M. Consultation on UTUC, Stockholm 2018 aspects of risk stratification: long-term results and follow-up. World J Urol. 2019 Nov;37(11):2289-2296. doi: 10.1007/s00345-019-02739-1. Epub 2019 Apr 3.

  PMID: 30944969 BACKGROUND

• Jung H, Giusti G, Fajkovic H, Herrmann T, Jones R, Straub M, Baard J, Osther PJS, Brehmer M. Consultation on UTUC, Stockholm 2018: aspects of treatment. World J Urol. 2019 Nov;37(11):2279-2287. doi: 10.1007/s00345-019-02811-w. Epub 2019 May 23.

  PMID: 31123852 BACKGROUND

• Marcq G, Foerster B, Abufaraj M, Matin SF, Azizi M, Gupta M, Li WM, Seisen T, Clinton T, Xylinas E, Mir MC, Schweitzer D, Mari A, Kimura S, Bandini M, Mathieu R, Ku JH, Guruli G, Grabbert M, Czech AK, Muilwijk T, Pycha A, D'Andrea D, Petros FG, Spiess PE, Bivalacqua T, Wu WJ, Roupret M, Krabbe LM, Hendricksen K, Egawa S, Briganti A, Moschini M, Graffeille V, Autorino R, John P, Heidenreich A, Chlosta P, Joniau S, Soria F, Pierorazio PM, Shariat SF, Kassouf W. Novel Classification for Upper Tract Urothelial Carcinoma to Better Risk-stratify Patients Eligible for Kidney-sparing Strategies: An International Collaborative Study. Eur Urol Focus. 2022 Mar;8(2):491-497. doi: 10.1016/j.euf.2021.03.018. Epub 2021 Mar 26.

  PMID: 33773965 BACKGROUND

• Shvero A, Abu-Ghanem Y, Laufer M, Dotan ZA, Zilberman DE, Mor Y, Portnoy O, Fridmen E, Winkler H, Kleinmann N. Endoscopic Treatment for Large Multifocal Upper Tract Urothelial Carcinoma. J Urol. 2021 Apr;205(4):1039-1046. doi: 10.1097/JU.0000000000001505. Epub 2020 Nov 20.

  PMID: 33216692 BACKGROUND

• Hendriks N, Baard J, Beerlage HP, Schout BMA, Doherty KSG, Pelger RCM, Kamphuis GM. Survival and Long-term Effects of Kidney-sparing Surgery Versus Radical Nephroureterectomy on Kidney Function in Patients with Upper Urinary Tract Urothelial Carcinoma. Eur Urol Open Sci. 2022 May 2;40:104-111. doi: 10.1016/j.euros.2022.04.007. eCollection 2022 Jun.

  PMID: 35638087 BACKGROUND

• Masson-Lecomte A, Birtle A, Pradere B, Capoun O, Comperat E, Dominguez-Escrig JL, Liedberg F, Makaroff L, Mariappan P, Moschini M, Rai BP, van Rhijn BWG, Shariat SF, Smith EJ, Teoh JYC, Soukup V, Wood R, Xylinas EN, Soria F, Seisen T, Gontero P. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Carcinoma: Summary of the 2025 Update. Eur Urol. 2025 Jun;87(6):697-716. doi: 10.1016/j.eururo.2025.02.023. Epub 2025 Mar 20.

  PMID: 40118741 BACKGROUND

• Ham WS, Park JS, Jang WS, Kim J. Nephron-Sparing Approaches in Upper Tract Urothelial Carcinoma: Current and Future Strategies. Biomedicines. 2022 Sep 8;10(9):2223. doi: 10.3390/biomedicines10092223.

  PMID: 36140325 BACKGROUND

• Soria F, Shariat SF, Lerner SP, Fritsche HM, Rink M, Kassouf W, Spiess PE, Lotan Y, Ye D, Fernandez MI, Kikuchi E, Chade DC, Babjuk M, Grollman AP, Thalmann GN. Epidemiology, diagnosis, preoperative evaluation and prognostic assessment of upper-tract urothelial carcinoma (UTUC). World J Urol. 2017 Mar;35(3):379-387. doi: 10.1007/s00345-016-1928-x. Epub 2016 Sep 7.

  PMID: 27604375 BACKGROUND

• Azawi NH, Naeraa SH, Subhi Y, Vasquez JL, Norus T, Dahl C, Thind P, Jensen JB. Oncological outcomes of radical nephroureterectomy for upper urinary tract urothelial neoplasia in Denmark. Scand J Urol. 2020 Feb;54(1):58-64. doi: 10.1080/21681805.2019.1710562. Epub 2020 Jan 16.

  PMID: 31942812 BACKGROUND

• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

  PMID: 33433946 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Juan L Vásquez, MD, PhD

  Zealand University Hospital

  STUDY DIRECTOR

Central Study Contacts

Juan L Vásquez, MD, PhD

CONTACT

+45 28947015; julv@regionsjaelland.dk

Stine H Reeler, MD

CONTACT

+45 23428443; sfhe@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): June 30, 2040
• Last Updated: December 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); DK (4)