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Prospective Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging

Primary Purpose

Non Muscle Invasive Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Narrow band imaging transurethral resection
Standard transurethral resection
Sponsored by
Paolo Puppo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Muscle Invasive Bladder Cancer focused on measuring bladder cancer, recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute for Cancer Research (IST)
  • Centro Urologico di Eccellenza ASL 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard transurethral resection

Narrow band imaging transurethral resection

Arm Description

Patients will be submitted to standard white light transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer

The system will be switched to narrow band imaging by simply pushing a button. Transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer will be performed; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer.

Outcomes

Primary Outcome Measures

Recurrence free survival rate

Secondary Outcome Measures

Detection rate

Full Information

First Posted
October 28, 2009
Last Updated
January 13, 2018
Sponsor
Paolo Puppo
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1. Study Identification

Unique Protocol Identification Number
NCT01004211
Brief Title
Prospective Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging
Official Title
A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paolo Puppo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Muscle Invasive Bladder Cancer
Keywords
bladder cancer, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard transurethral resection
Arm Type
Active Comparator
Arm Description
Patients will be submitted to standard white light transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer
Arm Title
Narrow band imaging transurethral resection
Arm Type
Experimental
Arm Description
The system will be switched to narrow band imaging by simply pushing a button. Transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer will be performed; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer.
Intervention Type
Procedure
Intervention Name(s)
Narrow band imaging transurethral resection
Intervention Description
Transurethral resection of bladder lesion by mean of narrow band imaging
Intervention Type
Procedure
Intervention Name(s)
Standard transurethral resection
Intervention Description
Transurethral resection of bladder lesion by mean of standard white light
Primary Outcome Measure Information:
Title
Recurrence free survival rate
Time Frame
One year
Secondary Outcome Measure Information:
Title
Detection rate
Time Frame
At the end of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Puppo, MD
Organizational Affiliation
National Institute for Cancer Research, Genoa, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute for Cancer Research (IST)
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Centro Urologico di Eccellenza ASL 1
City
Imperia
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19549255
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.
Results Reference
background
PubMed Identifier
20509796
Citation
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.
Results Reference
result
PubMed Identifier
22280855
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 recurrence. Eur Urol. 2012 May;61(5):908-13. doi: 10.1016/j.eururo.2012.01.018. Epub 2012 Jan 20.
Results Reference
result

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Prospective Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging

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