Upper Urinary Tract CarcinomaSINCERENCT05731622
Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC
An observational study of Upper Urinary Tract Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Urinary Tract Carcinoma
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2024to Sep 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspect of having non-metastatic UTUC
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
AmsterdamUMC
Amsterdam
Orlane Figaroa, MD, o.j.figaroa@amsterdamumc.nl
About this study
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
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
Read the 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.
- Conditions
- Upper Urinary Tract Carcinoma
- Keywords
- Intravesical recurrence, Mitomycin C, Ureteroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2 years
Secondary outcomes (1)
predictive factors for IVR
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study startFeb 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Urinary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce Baard, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Joyce Baard, MD, MSc, Principal investigator, AmsterdamUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731622
- Sponsor's protocol ID
- W22_369
- Acronym
- SINCERE
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05731622
- Acronym / sponsor ID
- SINCERE / W22_369
- Conditions
- Upper Urinary Tract Carcinoma
- Keywords
- Intravesical recurrence, Mitomycin C, Ureteroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspect of having non-metastatic UTUC
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
1 secondary outcome
predictive factors for IVR
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Upper Urinary Tract Carcinoma
RecruitingPhase 2/3
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Renal Pelvis and Ureter Urothelial Carcinoma
Active, not recruitingPhase 3
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
Advanced Bladder Urothelial Carcinoma, Advanced Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 3
Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer
Localized Renal Pelvis and Ureter Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma
RecruitingObservational study
Urinary Cell-Free DNA Liquid Biopsy for Urothelial Cancer Diagnosis and Origin Identification
Urothelial Carcinoma (UC), Upper Tract Urothelial Carcinoma
Active, not recruitingPhase 1/2
Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression
Advanced Solid Tumor Historically Known for High EphA2 Expression, Urothelial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Baard, MD, MSc principal investigator
AmsterdamUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Urinary Tract Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joyce Baard, MD, MSc (+31 020 444 0261, j.baard@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to and total number of Intravesical recurrences (IVR) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.