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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institute for Cancer Research, Italy
ClinicalTrials.gov Identifier:
NCT01004211
First received: October 28, 2009
Last updated: October 18, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Non Muscle Invasive Bladder Cancer
 Procedure: Narrow band imaging transurethral resection
Procedure: Standard transurethral resection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute for Cancer Research, Italy:

Primary Outcome Measures:
  • Recurrence free survival rate [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detection rate [ Time Frame: At the end of enrollment ] [ Designated as safety issue: No ]
  • 3 years recurrence-free survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 3 years progression-free survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 3 years overall survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: August 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard transurethral resection
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
 Procedure: Standard transurethral resection
Transurethral resection of bladder lesion by mean of standard white light
Experimental: Narrow band imaging transurethral resection
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.
 Procedure: Narrow band imaging transurethral resection
Transurethral resection of bladder lesion by mean of narrow band imaging

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004211

Locations
Italy
National Institute for Cancer Research (IST)
Genoa, Italy, 16132
Centro Urologico di Eccellenza ASL 1
Imperia, Italy
Sponsors and Collaborators
National Institute for Cancer Research, Italy
Investigators
Principal Investigator: Paolo Puppo, MD National Institute for Cancer Research, Genoa, Italy
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paolo Puppo, National Institute for Cancer Research, Italy
ClinicalTrials.gov Identifier: NCT01004211     History of Changes
Other Study ID Numbers: IST-NBI-2009
Study First Received: October 28, 2009
Last Updated: October 18, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by National Institute for Cancer Research, Italy:
bladder cancer
recurrence

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013