|- candidate number||28315|
|- NTR Number||NTR6879|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-dec-2017|
|- Secondary IDs||837001502 ZONMW|
|- Public Title||Reduceren van de4 kosten van de controle van patienten met niet-spier-invasief blaaskanker|
|- Scientific Title||Reducing costs of surveillance of patients with non-muscle invasive bladder cancer|
|- ACRONYM||URICA II|
|- hypothesis||1) Surveillance of patients with a urine test, followed by cystoscopy only when the urine test is positive, results in detection of a the same or a higher number of recurrences and is cost-effective and 2) urine diagnostics contribute to earlier detection of recurrences in patients at high-risk for recurrences or progression to potentially lethal MIBC (high-risk group)|
|- Healt Condition(s) or Problem(s) studied||Bladder cancer, Cytoscopy, Urine test|
|- Inclusion criteria||patients under surveillance for recurrences after a NMIBC primary tumor |
|- Exclusion criteria||under 21 years of age |
patients upgraded at reTUR to NMIBC
Patients presenting with MIBC
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-jan-2015|
|- planned closingdate||5-jul-2019|
|- Target number of participants||450|
|- Interventions||Cystoscopy is an invasive diagnostic procedure. Urine analysis can replace part of the cystoscopies.|
|- Primary outcome||15% extra recurrences detected in maximal care arm;
40% percentage decrease in cystoscopies in optimal care arm;
costs of optimal care vs classic care: 4000 euro less;
|- Secondary outcome||lower stage recurrences in high-risk group|
|- Timepoints||The intervention studied is the biomarker analysis of two urine samples from a patient taken a month prior to cystoscopy. In the maximal care arm the outcome of the urine tests will be communicated to the urology department of the relevant hospital in such a way that the urologist who performs the cystoscopy is aware of the test result: positive or negative. A positive urine test outcome means that one or both urine tests were positive and a negative outcome when both tests were negative. Patients with a negative urine test and a negative cystoscopy outcome will be scheduled for a next cystoscopy according to the guidelines. |
When the urine test is positive or negative in combination with a positive cystoscopy, the tumor will be resected and the patient will be scheduled for a next cystoscopy according to the guidelines. If the urine test is positive and cystoscopy is negative, the patient will be asked to return for another cystoscopy 3 months later. In these cases urine testing is again performed before the cystoscopy. When a tumor is detected at this cystoscopy the patient will be scheduled for TUR. If both tests are negative, the patient will return to a follow-up schedule according to the guidelines for his/her risk situation. If the urine tests are again positive and cystoscopy is negative, the patient will be scheduled for a CT/ureterorenoscopy/retrograde pyelography to examine the upper urinary tract. When positive, the tumor will be resected, when negative, the patient will return to a follow-up schedule according to the guidelines for his/her risk situation.
In the classic surveillance arm, urine samples will be obtained also before cystoscopy as in the maximal care arm. The urine tests will be performed at a convenient moment and the results will not be communicated to the urologist. A positive cystoscopy will be followed by a TUR. The MD/PhD student will regularly visit each hospital to obtain the data and include new patients. She/he will further provide follow-up schemes according to the EAU guidelines to be entered in each patientís file. The urologist/resident can use these to mark his/her decisions and this can then easily been extracted by the MD/PhD student for the database.
Follow up intervals in both arms of the study will be according to the EAU guidelines and we will enforce this in the different hospitals. In a limited number of cases (suspicion of CIS), fluorescence guided or narrow band cystoscopy will be carried out in the Amphia and St Franciscus hospitals. These cases will be included as a separate group, and analyzed separately.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. E.C. Zwarthoff|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. E.C. Zwarthoff|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||OBJECTIVE(S) / RESEARCH QUESTION(S): 1) to prove that it is possible to safely reduce the number of invasive cystoscopies during FUP of patients with non-muscle invasive bladder cancer (NMIBC) with a low/intermediate risk of recurrence or progression and 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. |
HYPOTHESIS: 1) Surveillance of patients with a urine test, followed by cystoscopy only when the urine test is positive, results in detection of a the same or a higher number of recurrences and is cost-effective and 2) urine diagnostics contribute to earlier detection of recurrences in patients at high-risk for recurrences or progression to potentially lethal MIBC (high-risk group)
STUDY DESIGN: This will be a multicenter two-armed prospective RCT. In the maximal care arm urine tests are performed prior to cystoscopy such that the urologist is aware of the outcome. In the classic care arm conventional follow-up is carried out, urines are analyzed as in the maximal care arm, but their outcome is not communicated. The data from both arms in terms of detected and missed recurrences will be used to calculate the performance of a virtual third optimal care arm in which follow-up is by urine tests with a cystoscopy only when the urine test is positive for patients entered with NMIBC in the low/intermediate groups. The data from classic and maximal care arms will be compared for the patients entered with high-risk NMIBC to determine whether more recurrences are detected in the maximal care arm and whether these recurrences are of lower stage.
STUDY POPULATION: patients under surveillance for recurrences after a NMIBC primary tumor who are 21 years or older.
INTERVENTION: urine analysis.
OUTCOME MEASURES: % extra recurrences detected in maximal care arm, % decrease in cystoscopies in optimal care arm, costs of optimal vs classic care, lower stage recurrences in high-risk group.
SAMPLE SIZE: 435 patients, 2*1418 urines, 449 recurrences
ANTICIPATED HEALTHCARE EFFICIENCY GAIN: > 40% fewer cystoscopies, 4000 Ä cost reduction per patient in the low/intermediate risk groups. Earlier detection of recurrences in high-risk group and stage regression, at additional costs.
TIME SCHEDULE: 36 months. Inclusion of patients under surveillance in the first 3 months, new patients thereafter. In the next 27 months urines will be sampled and analyzed. At the end 6 months are available to provide sufficient follow-up and for data analysis.
KEY WORDS: bladder cancer, non-muscle invasive, surveillance, cystoscopy, urine test
|- Main changes (audit trail)|
|- RECORD||7-dec-2017 - 16-dec-2017|