The Global randomized NBi bladder cancer study A Multi-Centre, International study to compare the use of Narrow Band Imaging (NBI) versus White light (WL) to assess recurrence of bladder cancer in terms of safety and efficacy.
Phase 3
- Conditions
- bladder cancer10004994
- Registration Number
- NL-OMON34696
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Patients scheduled for treatment of a primary/recurrent NMIBC
Patients should be aged 18 years or older
No tumours in the upper urinary tract
No previous irradiation of the pelvis
Exclusion Criteria
Gross hematuria at the time of TURB. (Note: Gross hematuria is defined as a heavy bladder bleeding resulting in marked amounts of blood in the urine, which may interfere with cystoscopy).
Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
* Pregnant (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>All lesions must be histological confirmed.<br /><br>The proportion of subjects with histology-confirmed tumors (Ta or T1) who have<br /><br>at least one such tumor found by NBI but not by white light cystoscopy.<br /><br>Comparison of the proportions of Group A and Group B subjects who undergo TURB<br /><br>for a histology-confirmed Ta or T1 tumor who have a recurrence (histology<br /><br>confirmed Ta or T1) found at either three or twelve months</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the persistence/recurrence of tumour at first follow up (3 months)<br /><br>after Narrow Band Imaging and TURB or White Light TURB in patients with NMIBC.<br /><br>To assess the peri-operative morbidity (30 days) of TURB between NBI and WL<br /><br>resection by using the Clavien score<br /><br>To define risk factors for the development of peri-operative morbidity after<br /><br>instrumental treatment.<br /><br>To assess the recurrence rate related to the surgeon performing the procedure<br /><br>To assess the recurrence rate related to additional treatment following TURB.</p><br>