Bladder CancerMOSAICNCT04391790
MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy
A study testing Cystectomy and modified urinary conduit and Cystectomy and standard urinary conduit ad modum Bricker in people with Bladder Cancer, run by Jørgen Bjerggaard Jensen at 5 sites in Denmark.
Trial summary
Cystectomy is the chosen treatment of bladder cancer in 400 cases every year in DK. In replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (Ad Modum Bricker). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Cystectomy and modified urinary conduit and Cystectomy and standard urinary conduit ad modum Bricker
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesDenmark
- Study dates
- 27 May 2020to 1 Sep 2024
- Phase
- Interventional
- 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
Who may be able to join
- Bladder cancer with the indication for robot assisted radical cystectomy
- Ileal conduit ad modum Bricker as planned urinary diversion
- Ability to understand the participant information orally and in writing
- Signed consent form
Who cannot join
- Previous abdominal or pelvic radiotherapy
- Previous major abdominal surgery involving resection of bowel or construction of an enteric stoma
- Urostomy planned on the left side of the abdomen
- Single kidney
- Complete ureteral duplication (either uni- or bilaterally), known at time of inclusion
- Pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Department of Urology, Aalborg University Hospital
Aalborg, 9100
Department of Urology, Aarhus University Hospital
Aarhus, 8200
Department of Urology, Rigshospitalet
Copenhagen, 2100
Department of Urology, Herlev and Gentofte Hospital
Herlev, 2730
Department of Urology, Odense University Hospital
Odense, 5000
About this study
Official title: Randomized Controlled Trial With a MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy - MOSAIC
Cystectomy is the chosen treatment of bladder cancer in 400 cases every year in DK. In replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (Ad Modum Bricker).
Ureteral strictures are diagnosed in 15% of the cystectomized patients, and these patients are at increased risk of infections, loss of renal function and repeated interventions. The left ureter is diagnosed with 70% of all strictures, presumably due to the construction of the urinary diversion.
A modified urinary diversion have been tested in two small studies. The modified diversion is prolonged with 5cm compared to the conventional urinary diversion. The prolongation permits the urinary diversion to reach both the left and the right side of the abdomen, resulting in greater resection of non-viably distal ureter and less mobilization of the left ureter, lowering the rates of strictures.
- Conditions
- Bladder Cancer
- Being tested
- Cystectomy and modified urinary conduit, Cystectomy and standard urinary conduit ad modum Bricker
- Keywords
- ureteral strictures, urinary diversion
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystectomy and modified urinary conduitProcedure or surgery
Also called Retrosigmoid conduit
The modified retrosigmoid conduit is extended aorund 5 cm, so the left ureter does not have to cross under the mesentery wheras the presumed more robust ileal segment does.
Cystectomy and standard urinary conduit ad modum BrickerProcedure or surgery
Also called Conventional ileal conduit
The conduit is constructed using approximately 15 cm of terminal ileum and placed in the right side of the abdomen. In order for the left ureter to reach the conduit, it is mobilized behind the sigmoideum to the conduit.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Study subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker Receives: Procedure: Cystectomy and standard urinary conduit ad modum Bricker |
| Intervention | Experimental | Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit Receives: Procedure: Cystectomy and modified urinary conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strictures
Number of participants with benign strictures in the left ureter
Measured: Within 2 years after cystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start27 May 2020
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multicenter, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jørgen Bjerggaard Jensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jørgen Bjerggaard Jensen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391790
- Sponsor's protocol ID
- MOSAIC
- Other IDs
- DaBlaCa-16
- Acronym
- MOSAIC
- Status last verified
- Apr 2023
- First submitted
- 13 May 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial With a MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy - MOSAIC
- ClinicalTrials.gov ID
- NCT04391790
- Acronym / sponsor ID
- MOSAIC / MOSAIC
- Conditions
- Bladder Cancer
- Keywords
- ureteral strictures, urinary diversion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Jørgen Bjerggaard JensenUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 18 May 2020 (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.
Cystectomy is the chosen treatment of bladder cancer in 400 cases every year in DK. In replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (Ad Modum Bricker).
Ureteral strictures are diagnosed in 15% of the cystectomized patients, and these patients are at increased risk of infections, loss of renal function and repeated interventions. The left ureter is diagnosed with 70% of all strictures, presumably due to the construction of the urinary diversion.
A modified urinary diversion have been tested in two small studies. The modified diversion is prolonged with 5cm compared to the conventional urinary diversion. The prolongation permits the urinary diversion to reach both the left and the right side of the abdomen, resulting in greater resection of non-viably distal ureter and less mobilization of the left ureter, lowering the rates of strictures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, multicenter, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Cystectomy and standard urinary conduit ad modum BrickerStudy subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker |
| Intervention | Experimental | Procedure: Cystectomy and modified urinary conduitSubject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bladder cancer with the indication for robot assisted radical cystectomy
- Ileal conduit ad modum Bricker as planned urinary diversion
- Ability to understand the participant information orally and in writing
- Signed consent form
Key exclusion criteria (6 listed)
- Previous abdominal or pelvic radiotherapy
- Previous major abdominal surgery involving resection of bowel or construction of an enteric stoma
- Urostomy planned on the left side of the abdomen
- Single kidney
- Complete ureteral duplication (either uni- or bilaterally), known at time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cystectomy and modified urinary conduitAlso: Retrosigmoid conduitThe modified retrosigmoid conduit is extended aorund 5 cm, so the left ureter does not have to cross under the mesentery wheras the presumed more robust ileal segment does. | Procedure or surgery | Intervention |
| Cystectomy and standard urinary conduit ad modum BrickerAlso: Conventional ileal conduitThe conduit is constructed using approximately 15 cm of terminal ileum and placed in the right side of the abdomen. In order for the left ureter to reach the conduit, it is mobilized behind the sigmoideum to the conduit. | Procedure or surgery | Control |
Primary outcome
Strictures
Time frame: Within 2 years after cystectomy
Number of participants with benign strictures in the left ureter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cystectomy and modified urinary conduit and Cystectomy and standard urinary conduit ad modum Bricker in people with Bladder Cancer, run by Jørgen Bjerggaard Jensen at 5 sites in Denmark.
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 4 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strictures (time frame: Within 2 years after cystectomy). 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 27 Apr 2023.