Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC

NCT05731622 | Recruiting

• 1 other identifier: W22_369
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Upper Urinary Tract Carcinoma

Keywords

Intravesical recurrence; Mitomycin C; Ureteroscopy

Outcome Measures

Primary Outcomes (3)

• Time to and total number of Intravesical recurrences (IVR)

  What is the time to and total number of IVR 2 years after ureteroscopy (diagnostic or treatment) with SI-MMC for UTUC

  2 years

• Time to and total number of IVR after endoscopic vs radical treatment

  What is the time to and total number of IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy

  2 years

• Time to and total IVR after diagnostic ureteroscopy in patients who received final treatment by RNU

  Is there an additional value of SI-MMC on total and time to IVR after RNU in patients who were evaluated by ureteroscopy prior to RNU. Outcome measurement (time to IVR and total IVR) will be compared to a historical cohort who did not receive Mitomycin C to evaluate the additional effect

  2 years

Secondary Outcomes (1)

• predictive factors for IVR

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspect of having non-metastatic UTUC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

AmsterdamUMC

Amsterdam, Netherlands

RECRUITING

Study Officials

• Joyce Baard, MD, MSc

  AmsterdamUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce Baard, MD, MSc

CONTACT

+31 020 444 0261; j.baard@amsterdamumc.nl

Orlane Figaroa, MD

CONTACT

+31 020 444 0261; o.j.figaroa@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: drs J. Baard Urologist (PI)

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 16, 2023
• Study Start: February 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

NL (1)