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

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ClinicalTrials.gov Identifier: NCT01004211
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Puppo, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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.

Condition or disease Intervention/treatment Phase
Non Muscle Invasive Bladder Cancer Procedure: Narrow band imaging transurethral resection Procedure: Standard transurethral resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : August 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Recurrence free survival rate [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Detection rate [ Time Frame: At the end of enrollment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004211


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

Publications of Results:
Other Publications:
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Responsible Party: Paolo Puppo, MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT01004211     History of Changes
Other Study ID Numbers: IST-NBI-2009
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by Paolo Puppo, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
bladder cancer
recurrence

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