1) To prove that it is possible to safely reduce the number of invasive cystoscopies during follow-up (FUP) of patients with NMIBC with a low/intermediate risk of recurrence or progression. 2) To prove that addition of urine tests to the follow-up…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 15% more recurrences detected in the maximal care arm in patients in the
low/intermediate risk group.
- Proof that in the optimal care arm (intended to be the future follow-up
procedure) is safe regarding detected versus missed recurrences.
- Calculation of % of cystoscopies that would be unnecessary in the future.
- Cost-effectiveness of this strategy.
Secondary outcome
- 15% more recurrences detected in patients with a primary high-risk tumor.
- Indication that these are of lower stage.
- Cost-effectiveness.
Background summary
Cancer of the urinary bladder is the fifth most common cancer in the western
world. Bladder tumors present either as non-muscle-invasive bladder cancer
(NMIBC) or as muscle-invasive bladder cancer (MIBC). Over 60% of patients with
NMIBC develop multiple recurrences and they are at risk for progression to
MIBC. The need to monitor these patients, often for the rest of their life,
makes bladder cancer the costliest cancer per patient. On average patients have
20 cystoscopies in the first 10 years of follow-up. We estimate that between
2-4 million cystoscopies are carried out yearly in the EU and USA. In the
previous decade we have demonstrated that assays for tumor-associated DNA
changes can detect recurrences in cells obtained from voided urine. The
prospective trial represents the pivotal step to ensure that urine testing is
taken up in the guidelines of the EAU (European Association of Urology) and in
the regular health care system.
Study objective
1) To prove that it is possible to safely reduce the number of invasive
cystoscopies during follow-up (FUP) of patients with NMIBC with a
low/intermediate risk of recurrence or progression.
2) To prove that addition of urine tests to the follow-up of patients with
NMIBC at a high risk of recurrence and progression leads to earlier detection
of potentially dangerous recurrences.
Study design
This will be a multicenter two-armed prospective randomized clinical trial
(RCT).
Study burden and risks
Included patients are asked to provide two urine samples up to one month before
each regular cystoscopy. The samples are to be sent by mail to the laboratory
at Erasmus MC. There are no extra costs for the patients. The maximal number of
these events is 12 during the duration of the project. There are no extra
visits to the hospital.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
1) (Previous) primary NMIBC
2) Currently under surveillance for possible recurrent disease
3) Monitored by the urology patient archives in the participating hospitals
Exclusion criteria
1) Patients upgraded at reTUR to MIBC
2) Patients presenting with MIBC
3) Patients below 21 years of age. ;After the initial TUR, a second TUR (reTUR) is recommended for patients with pT1 tumors. This is to establish whether resection was radical and when there is remaining tumor whether the tumor is muscle-invasive. In the latter case these patients will be excluded because they do not belong to the NMIBC category
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 | NL50879.078.14 |