The Danish Bladder Cancer Group 23 Study - A European Study on Cancer in the Upper Urinary Tract
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZealand University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with confirmed histopathology of UTUC
Age ≥ 18 years
Informed patient consent
Disqualifiers
Patient not willing or able to give informed consent
Trial population
The study population consists of patients diagnosed with UTUC on a histopatohological specimen from departments of urology within Europe and the USA.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Kidney sparing surgery for high-risk upper urinary tract urothelial carcinoma
Procedure/SurgeryThis 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".
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: All patientens diagnosed with upper urinary tract urothelial carcinoma (UTUC)1 intervention
Trial outcomes
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.
Time frame
From the end of enrollement until 10 years after inclusion or time of deathSecondary outcomes
1
Cancer specific survival
Cancer specific survival will be assessed by recording the cause of death for all enrolled patients throughout the follow-up period. At each scheduled follow-up time point (1, 3, 5, and 10 years), survival status will be updated, and if applicable, the cause of death will be registered in the electronic case report form (eCRF) as either UTUC-related or due to other causes. This distinction allows for accurate estimation of cancer-specific mortality and evaluation of the oncological safety of different treatment strategies, including kidney-sparing surgery (KSS) versus radical nephroureterectomy (RNU).
Time frame
From the end of enrollement until 10 years after inclusion or time of death2
Recurrences
We record the following types of recurrence: Any recurrence (local or distant) following radical nephroureterectomy (RNU) or kidney-sparing surgery (KSS). Recurrence is documented based on follow-up imaging studies and/or histopathological confirmation. Intravesical recurrence following RNU or KSS. All bladder recurrences identified during surveillance cystoscopy are recorded. Additionally, we document any prior or concomitant bladder cancer, in order to differentiate between pre-existing bladder cancer and secondary bladder cancer potentially related to UTUC.
Time frame
From enrollement until five years either after diagnosis or last recurrence according to current follow up guidelines.3
Progression
Progression after KSS Progression will be assessed based on histopathological evaluation of local biopsy specimens or subsequent radical nephroureterectomy (RNU) specimens. Both grade progression and stage progression will be recorded according to the WHO 2004/2016 grading system for UTUC.
Time frame
From enrollment until five years of follow up4
Renal function
Renal function is monitored using serum creatinine (µmol/L) measurements at baseline and at follow-up scheduled at 1, 3, 5, and 10 years. Creatinine values obtained within 3 months prior to each follow-up time point are accepted for analysis. The endpoint is the development of chronic kidney disease (CKD) stage ≥3b, defined as an estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m². eGFR is calculated using standard formulas (CKD-EPIkrea), without adjustment for race.
Time frame
from enrollment until ten yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zealand University Hospital
Lead sponsor
Aarhus University Hospital Skejby
Collaborator
Rigshospitalet, Denmark
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Source ClinicalTrials.gov