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A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non Muscle Invasive Bladder Cancer

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Trial Information

A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence free survival rate

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Paolo Puppo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute for Cancer Research, Genoa, Italy

Authority:

Italy: Ethics Committee

Study ID:

IST-NBI-2009

NCT ID:

NCT01004211

Start Date:

August 2009

Completion Date:

October 2013

Related Keywords:

  • Non Muscle Invasive Bladder Cancer
  • bladder cancer
  • recurrence
  • Urinary Bladder Neoplasms

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