Previous research demonstrates that in some cases, where the tumor of the patient contains a mutation in FGFR3, the mutation can not be detected in urine derived from the same patient. Our hypothesis states that this urine does not contain any tumor…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The results of either no mutation or a mutation in FGFR3.
There are 11 mutations known in FGFR3, which are analyzed simultaneously.
Secondary outcome
n.v.t.
Background summary
Recent independent studies have shown that 85% of the non-muscle invasive
urothelial carcinomas contain a mutation in the Fibroblast Growth Factor
Receptor-3 (FGFR3) gene. We developed a SnaPshot assay to detect this mutation
in DNA derived from urine samples. Eventually our aim is to detect recurrences
with this assay at an early stage and hereby to reduce the amount of
cystoscopies carried out. Additionally this will reduce physical and mental
distress in patients caused by a cystoscopy.
Study objective
Previous research demonstrates that in some cases, where the tumor of the
patient contains a mutation in FGFR3, the mutation can not be detected in urine
derived from the same patient. Our hypothesis states that this urine does not
contain any tumor cells at the moment of collection, leading to an impaired
detection of FGFR3 in urine samples.
In order to test the hypothesis urine (collected throughout the whole day)
derived from bladder cancer patients should be collected for multiple days
prior to being operated. This way the optimal moment for urine collection can
be determined.
Study design
Patients, who are scheduled for a transurethral resection of a bladder tumor,
are selected. Ten days prior to the operation all urine of these patients is
collected and picked up twice a day, for example at 9:00 and 16:00 o'clock.
DNA is isolated from the urine samples and used for FGFR3 mutation analysis.
Study burden and risks
Patients should collect all urine for ten days.
There are no risks associated with participation in this study.
Postbus 2040
3000 CA Rotterdam
Nederland
Postbus 2040
3000 CA Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients diagnosed with bladder cancer
Exclusion criteria
--
Design
Recruitment
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 |
---|---|
CCMO | NL19144.078.07 |