Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Upper Urinary Tract Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Time to and total number of Intravesical recurrences (IVR) [Time frame: 2 years]
- Time to and total number of IVR after endoscopic vs radical treatment [Time frame: 2 years]
- Time to and total IVR after diagnostic ureteroscopy in patients who received final treatment by RNU [Time frame: 2 years]
Secondary outcome measures (1)
- predictive factors for IVR [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- AmsterdamUMC — Amsterdam
Identifiers
NCT: NCT05731622 · W22_369