Non Muscle Invasive Bladder Cancer Clinical Trial
Official title:
A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.
To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective within patient trials but only as an "add on" procedure. This results in a bias that does not allow to determine the real impact of such innovative technologies on bladder cancer management. Hereby we propose the first prospective randomized trial which compares narrow band imaging trans urethral resection as a stand alone procedure versus white light transurethral resection. The primary end point is to assess the recurrence rate of bladder cancer lesions with each treatment modality. The study is designed to disclose an inferior recurrence rate (estimated 10%) in the group treated by narrow band imaging transurethral resection respect to the control group, treated by standard transurethral resection.
Status | Completed |
Enrollment | 188 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients must be older than 18 years of age and female patients who are pregnant, breast feeding or not on adequate contraceptive measures will be excluded. - All patients will provide a written informed consent prior to the study. - Consecutive patients from 2 centers in Liguria (National Institute for Cancer Research - Genova and Centro Urologico di Eccellenza ASL 1 - Imperia) with overt or suspected non muscle invasive bladder cancer, including Cis detected by mean of random biopsies or a positive urinary cytology, will be included in the study and randomized to 2 treatments A, B arms. Exclusion Criteria: - Patients with muscle invasive bladder cancer will be excluded. - Patients submitted to immediate radical cystectomy after transurethral resection, irrespective of the clinical stage, will be excluded. |
Country | Name | City | State |
---|---|---|---|
Italy | National Institute for Cancer Research (IST) | Genoa | |
Italy | Centro Urologico di Eccellenza ASL 1 | Imperia |
Lead Sponsor | Collaborator |
---|---|
Paolo Puppo |
Italy,
Naselli A, Introini C, Bertolotto F, Spina B, Puppo P. Feasibility of transurethral resection of bladder lesion performed entirely by means of narrow-band imaging. J Endourol. 2010 Jul;24(7):1131-4. doi: 10.1089/end.2010.0042. — View Citation
Naselli A, Introini C, Bertolotto F, Spina B, Puppo P. Narrow band imaging for detecting residual/recurrent cancerous tissue during second transurethral resection of newly diagnosed non-muscle-invasive high-grade bladder cancer. BJU Int. 2010 Jan;105(2):208-11. doi: 10.1111/j.1464-410X.2009.08701.x. Epub 2009 Jun 22. — View Citation
Naselli A, Introini C, Timossi L, Spina B, Fontana V, Pezzi R, Germinale F, Bertolotto F, Puppo P. A randomized prospective trial to assess the impact of transurethral resection in narrow band imaging modality on non-muscle-invasive bladder cancer recurre — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence free survival rate | One year | ||
Secondary | Detection rate | At the end of enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06020807 -
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
|
||
Recruiting |
NCT04452591 -
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
|
Phase 3 | |
Recruiting |
NCT06167356 -
Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.
|
||
Withdrawn |
NCT01799499 -
A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)
|
N/A | |
Completed |
NCT02343614 -
Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
Recruiting |
NCT05945108 -
Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER
|
||
Recruiting |
NCT06287541 -
The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
|
N/A | |
Recruiting |
NCT06181266 -
A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
|
Phase 1 | |
Terminated |
NCT02982395 -
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
|
Phase 3 | |
Completed |
NCT06205277 -
Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer
|
||
Completed |
NCT01731652 -
Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer
|
Phase 2 | |
Recruiting |
NCT03421236 -
Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
|
Phase 1 | |
Active, not recruiting |
NCT04387461 -
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
|
Phase 2 | |
Recruiting |
NCT06111235 -
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
|
Phase 3 | |
Recruiting |
NCT02895620 -
Effect on Xpert® Bladder Test of Urines Inflammatory Milieu Induced by BCG Treatment of Patients With NMIBC
|
N/A | |
Active, not recruiting |
NCT05981131 -
Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)
|