Clinical trial NCT05731622: Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC
Official title: Effect of a Single Instillation of Mitomycin C on the Intravesical Recurrence Rate After Ureteroscopy for Upper Tract Urothelial Carcinoma: A Prospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Upper Urinary Tract Carcinoma
Keywords: Intravesical recurrence
Mitomycin C
Ureteroscopy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspect of having non-metastatic UTUC

Brief summary: The goal of this observational study is to evaluate the intravesical recurrence (IVR) rate after ureteroscopy (diagnostic or treatment) for upper tract urothelial carcinoma (UTUC) followed by an adjuvant single instillation of Mitomycin C (SI-MMC).

The main question it aims to answer are:

* What is the total and time to IVR after 2 years after ureteroscopy (diagnostic or treatment) for UTUC
* How is the IVR compared with a historical cohort (no SI-MMC)
* What is the time to IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy (RNU)
* What is the additional value of a SI-MMC on time to IVR after RNU + adjuvant MMC in patients who were evaluated by ureteroscopy prior to RNU

Detailed description: The primary objective is to evaluate the IVR rate after ureteroscopy (diagnostic or treatment) followed by an single instillation of MMC (SI-MMC), in patients with clinically non-metastatic UTUC.

The main question we aim to answer are:

* What is the total and time to IVR after 2 years after ureteroscopy (diagnostic or treatment) for UTUC
* How is the IVR compared with a historical cohort (no SI-MMC)
* What is the time to IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy
* What is the additional value of a SI-MMC on time to IVR after RNU + adjuvant MMC in patients who were evaluated by ureteroscopy prior to RNU.

Secondary objectives include the evaluation of possible predictive factors for IVR rate.

Study design: Multicentre, prospective cohort study in a clinical setting,

Study population: All adult patients (age ≥18 years) with a (suspicion of a) urothelial carcinoma of the upper urinary tract undergoing ureteroscopy, either diagnostic or as endoscopic kidney sparing treatment, followed by a post-operative single instillation of Mitomycin C.

Intervention: No intervention

Main study parameters/endpoints:

The primary endpoint of this study is the time to and total intravesical recurrences (histological proven) in the first 24 months following ureteroscopy (diagnostic or treatment) for UTUC followed a single instillation of Mitomycin C.

Secondary Objective(s): to evaluate possible predictive factors for IVR rate looking at gender, tumour size, tumour focality, tumour location, postoperative stent placement, use of an ureteral access sheath, timing of administration of MMC, the performance of an endoscopic biopsy during ureteroscopy.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Investigations during follow-up include cystoscopy, ureteroscopy and CT-urography, which is in line with the standardized care and will not include additional investigations.

Eligibility criteria: Inclusion Criteria:

* All patients suspect for having non-metastatic disease and planned for ureteroscopy (diagnostic or treatment) and adjuvant single instillation of Mitomycin C
* Age ≥18 years
* Written informed consent

Exclusion Criteria:

* History of histological proven urothelial carcinoma of the bladder, including carcinoma in situ
* History of histological proven UTUC in the contralateral kidney
* Concurrent bladder tumour found pre-operatively or per-operatively
* Patients where it is not feasible to obtain histology by biopsies intra-operatively
* Known Mitomycin C
* Renal transplantation

Primary outcomes:
measure: Time to and total number of Intravesical recurrences (IVR)
timeFrame: 2 years
measure: Time to and total number of IVR after endoscopic vs radical treatment
timeFrame: 2 years
measure: Time to and total IVR after diagnostic ureteroscopy in patients who received final treatment by RNU
timeFrame: 2 years
Secondary outcomes:
measure: predictive factors for IVR
timeFrame: 2 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AmsterdamUMC
Study officials:
affiliation: AmsterdamUMC
name: Joyce Baard, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: