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
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
progression free survival at 2 years after diagnosis
Secondary outcome
time to definitive treatment, quality of life, healthcare costs and
cost-effectiveness
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
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
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
Design
Recruitment
Medical products/devices used
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 |