NCT01180478

Brief Summary

The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
965

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

April 25, 2018

Completed
Last Updated

April 25, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

August 10, 2010

Results QC Date

August 10, 2017

Last Update Submit

March 27, 2018

Conditions

Bladder Cancer

Keywords

Bladder CancerUrothelial carcinomaStage pTa or pT1NMIBC Ta/T1Narrow Band ImagingWhite Light CystoscopyTransurethral resectionSuperficial bladder tumorPositive urine cytology

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Recurrence and Recurrence Rate at 1 Year Following Narrow Band Imaging and TURB (Arm A) Versus White Light Trans Urethral Resection of Bladder Cancer (TURB) (Arm B) in Patients With Non Muscle Invasive (pTa/T1) Bladder Cancer.

    The primary outcome measure was recurrence rate at 1 year. A recurrence was defined as the new occurrence of a bladder cancer at the same site as or at a different site from the index cancer.

    1 year after treatment

Secondary Outcomes (4)

  • Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection

    3 months after treatment

  • Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.

    30 days

  • Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.

    peri-operative

  • Recurrence Rate Related to Additional Treatment Following TURB.

    Until 135 days

Study Arms (2)

Narrow Band Imaging

OTHER

Narrow Band Imaging (NBI)

Device: Narrow Band Imaging

White Light Trans Urethral Resection

OTHER

White Light Trans Urethral Resection

Device: White Light

Interventions

White LightDEVICE

White Light Cystoscopy

White Light Trans Urethral Resection
Narrow Band ImagingDEVICE

Narrow Band Imaging

Narrow Band Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for treatment of primary or recurrent non-muscle invasive bladder cancer
  • Patients greater than 18 years of age
  • No tumors in the upper tract (kidneys or ureters)
  • No previous pelvic radiation

You may not qualify if:

  • Gross hematuria at the time of resection making visualization with NBI not possible
  • Participation in other clinical studies with investigations drugs concurrently or within 30 days.
  • Pregnancy
  • Conditions associated with a risk of poor compliance or unwilling to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder NeoplasmsCarcinoma, Transitional Cell

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Limitations and Caveats

There is a possibility of observer bias favouring NBI as a limitation of this single-blind study

Results Point of Contact

Title
J. de la Rosette, chairman CROES
Organization
CROES
info@croesoffice.org
+31 20 5666030

Study Officials

  • Jean de la Rosette, MD

    AMC University Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2010

First Posted

August 12, 2010

Study Start

August 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 25, 2018

Results First Posted

April 25, 2018

Record last verified: 2018-03