Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC
NCT ID: NCT05731622
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-02-29
2026-09-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Joyce Baard
drs J. Baard Urologist (PI)
Principal Investigators
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Joyce Baard, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
AmsterdamUMC
Locations
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AmsterdamUMC
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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W22_369
Identifier Type: -
Identifier Source: org_study_id
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