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

January 30, 2024 updated by: Joyce Baard, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Effect of a Single Instillation of Mitomycin C on the Intravesical Recurrence Rate After Ureteroscopy for Upper Tract Urothelial Carcinoma: A Prospective, Multicenter Study

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients suspect of having non-metastatic UTUC

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to and total number of Intravesical recurrences (IVR)
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictive factors for IVR
Time Frame: 2 years
to evaluate possible predictive factors for IVR rate looking different variables by multivariate logistic regression; with the dependent variable IVR and independent variables: gender (male/ female), tumour size (< 2cm/ >2cm), tumour focality (unifocal/ multifocal), tumour invasiveness (invasive/ non-invasive), tumour location (ureter/ puelocaliceal), use of Urethral access sheath (yes/no), use of postoperative stent (yes/ no), timing of MMC administartion (<24h/>24h)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

  • Principal Investigator: Joyce Baard, MD, MSc, AmsterdamUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W22_369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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