The Global randomized NBi bladder cancer study A Multi-Centre, International study to compare the use of Narrow Band Imaging (NBI) versus White light (WL) to assess recurrence of bladder cancer in terms of safety and efficacy.

The Global randomized NBi bladder cancer study A Multi-Centre, International study to compare the use of Narrow Band Imaging (NBI) versus White light (WL) to assess recurrence of bladder cancer in terms of safety and efficacy. - NBI vs White light TURB

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34696

Enrollment

Registered

2010-09-23

Start date

2010-07-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer

Interventions

NBI vs white light

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients scheduled for treatment of a primary/recurrent NMIBC Patients should be aged 18 years or older No tumours in the upper urinary tract No previous irradiation of the pelvis

Exclusion criteria

Exclusion criteria: Gross hematuria at the time of TURB. (Note: Gross hematuria is defined as a heavy bladder bleeding resulting in marked amounts of blood in the urine, which may interfere with cystoscopy). Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days. * Pregnant (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).

Design outcomes

Primary

Measure	Time frame
All lesions must be histological confirmed. The proportion of subjects with histology-confirmed tumors (Ta or T1) who have at least one such tumor found by NBI but not by white light cystoscopy. Comparison of the proportions of Group A and Group B subjects who undergo TURB for a histology-confirmed Ta or T1 tumor who have a recurrence (histology confirmed Ta or T1) found at either three or twelve months	—

Measure

Time frame

All lesions must be histological confirmed. The proportion of subjects with histology-confirmed tumors (Ta or T1) who have at least one such tumor found by NBI but not by white light cystoscopy. Comparison of the proportions of Group A and Group B subjects who undergo TURB for a histology-confirmed Ta or T1 tumor who have a recurrence (histology confirmed Ta or T1) found at either three or twelve months

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Secondary

Measure	Time frame
To assess the persistence/recurrence of tumour at first follow up (3 months) after Narrow Band Imaging and TURB or White Light TURB in patients with NMIBC. To assess the peri-operative morbidity (30 days) of TURB between NBI and WL resection by using the Clavien score To define risk factors for the development of peri-operative morbidity after instrumental treatment. To assess the recurrence rate related to the surgeon performing the procedure To assess the recurrence rate related to additional treatment following TURB.	—

Measure

Time frame

To assess the persistence/recurrence of tumour at first follow up (3 months) after Narrow Band Imaging and TURB or White Light TURB in patients with NMIBC. To assess the peri-operative morbidity (30 days) of TURB between NBI and WL resection by using the Clavien score To define risk factors for the development of peri-operative morbidity after instrumental treatment. To assess the recurrence rate related to the surgeon performing the procedure To assess the recurrence rate related to additional treatment following TURB.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)