NCT05979909Not yet recruitingPhase 1
Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
Preventing Intravesical Recurrence in Patients With Urothelial Carcinoma of the Upper Urinary Tract: a Pilot Randomized Trial of a Single Prophylactic Bladder Instillation of Mitomycin C After Diagnostic Ureteroscopy
Source: ClinicalTrials.gov · Last updated 7 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 31 Jul 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- McMaster University
- Diseases
- Bladder cancer
- NCT number
- NCT05979909
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 1 Sept 2023 to the primary completion date, 30 Sept 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or concomitant urothelial carcinoma of the bladder
Other illness
- History of UTUC
- Untreated urinary tract infection
- Suspected or confirmed perforation of the upper or lower urinary tract
- Lower urinary tract fistula
- Known hypersensitivity to mitomycin C
Other
- Ureteroscopy within the preceding six months
- Leukopenia or thrombocytopenia
- ECOG performance status 2 or greater
- Pregnancy or breastfeeding
- Lack of capacity to consent
Who the study is looking for
- Suspected upper tract urothelial carcinoma (UTUC)
- Diagnostic ureteroscopy required
- Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.