The aim of this study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with an outpatient biopsy for histological confirmation, is a faster, safer, cheaper and therefore more cost-effective way to detect or…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>progression free survival at 2 years after diagnosis</p>
Secondary outcome
<p>time to definitive treatment, quality of life, healthcare costs and cost-effectiveness</p>
Background summary
Muscle invasive bladder cancer (MIBC) is one of the very few types of cancer for which the prognosis has not improved for decades. About 50% of the 2000 patients per year in the Netherlands will die from the disease within 5 years despite curative local treatment. This suggests that in many patients the disease has already metastasized at the time of diagnosis, even though imaging shows no metastasis. We hypothesise that the standard local staging method, the transurethral resection of the bladder tumour (TURBT), is partly responsible for tumour cell spread, because this procedure cuts through the tumour.
Study objective
The aim of this study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with an outpatient biopsy for histological confirmation, is a faster, safer, cheaper and therefore more cost-effective way to detect or eliminate muscle invasion in bladder cancer.
Study design
Two-arm multicenter randomised controlled trial
Intervention
mpMRI of the bladder with outpatient biopsy of the tumour
Study burden and risks
The burden and risks to participate in BladParadigm are limited. No extra hospital visits are required, filling in the questionnaires takes 5 minutes maximum per questionnaire, with a maximum of 4 questionnaires in total
A.G. van der Heijden
Geert Grooteplein 10
Nijmegen 6525 GA
Netherlands
0650162128
bladparadigm@radboudumc.nl
A.G. van der Heijden
Geert Grooteplein 10
Nijmegen 6525 GA
Netherlands
0650162128
bladparadigm@radboudumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Patients (18+ years of age) with clinically suspected MIBC, without lymph node or distant metastases, written informed consent
Exclusion criteria
Unable or unwilling to undergo mpMRI; Unfit for TURBT; Unfit for definitive treatment with curative intent; A history of cancer, including bladder cancer, except non-melanoma skin cancer or prostate cancer on active surveillance, or history of a solid tumor but disease-free ≥5 years since last treatment
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05779631 |
| CCMO | NL83685.091.23 |
| Research portal | NL-007019 |