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NCT Number: NCT01004211

Prospective 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.

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Key information

Conditions

Non Muscle Invasive Bladder Cancer Carcinoma Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Cancer Research (IST), Genoa, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Narrow band imaging transurethral resection

Procedure

Transurethral resection of bladder lesion by mean of narrow band imaging

Standard transurethral resection

Procedure

Transurethral resection of bladder lesion by mean of standard white light

Primary outcomes

  1. Recurrence free survival rate

    Time frame: One year

Secondary outcomes

  1. Detection rate

    Time frame: At the end of enrollment

Sponsors and collaborators

Lead sponsor

Paolo Puppo

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2009
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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