UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004545 |
|---|---|
| Receipt number | R000005430 |
| Scientific Title | A Multi-Centre, international study to compare use of Narrow Band Imaging (NBI) versus White light Imaging (WLI) during TURBT to assess recurrence of bladder cancer in terms of safety and efficacy. |
| Date of disclosure of the study information | 2010/11/15 |
| Last modified on | 2018/05/30 09:36:25 |
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Basic information
Public title
A Multi-Centre, international study to compare use of Narrow Band Imaging (NBI) versus White light Imaging (WLI) during TURBT to assess recurrence of bladder cancer in terms of safety and efficacy.
Acronym
THE GROBAL RANDOMIZED NBI BLADDER CANCER STUDY
Scientific Title
A Multi-Centre, international study to compare use of Narrow Band Imaging (NBI) versus White light Imaging (WLI) during TURBT to assess recurrence of bladder cancer in terms of safety and efficacy.
Scientific Title:Acronym
THE GROBAL RANDOMIZED NBI BLADDER CANCER STUDY
Region
| Japan | North America | Europe |
Condition
Condition
non muscle-invasive bladder cancer (NMIBC)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the recurrence rate at 1 year following Narrow Band Imaging and TURB (Arm A) with White Light Trans Urethral Resection of Bladder cancer (TURB) (Arm B) in patients with NMIBC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All lesions must be histological confirmed.
The proportion of subjects with histology-confirmed tumours (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 tumour who have a recurrence (histology confirmed Ta or T1) found at either three or twelve months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
All patients in Group A will be treated with WL and NBI. The surgeon performing the follow up must preferably be different from the one performing the TURB. Patients will be followed during hospital stay, after 3 and 12 months at a minimum depending on stage and grade of tumours. All positive or suspect areas will be resected/biopsied using WL or NBI technique. The whole procedure will be recorded. At three months follow up patients will undergo WL cystoscopy and possible recurrence will be searched for and need histological confirmation. The study is designed to disclose a reduced recurrence rate at 1 year (estimated 10%) in the group treated by NBI TURB compared to the control group, treated by WL TURB.
Interventions/Control_2
All patients in Group B will be treated with WL. The surgeon performing the follow up must preferably be different from the one performing the TURB. Patients will be followed during hospital stay, after 3 and 12 months at a minimum depending on stage and grade of tumours. All positive or suspect areas will be resected/biopsied using WL technique. The whole procedure will be recorded. At three months follow up patients will undergo WL cystoscopy and possible recurrence will be searched for and need histological confirmation. The study is designed to disclose a reduced recurrence rate at 1 year (estimated 10%) in the group treated by NBI TURB compared to the control group, treated by WL TURB.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for treatment of a primary NMIBC
Patients should be aged 18 years or older
No tumours in the upper urinary tract
No previous irradiation of the pelvis
Key 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 or breast-feeding (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). Why, we do not inject anything
Target sample size
980
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof Jean de la Rosette |
Organization
AMC University Hospital
Division name
the Department of Urology
Zip code
Address
Meibergdreef 9, 1105 AZ, Amsterdam
TEL
020-566-9111
info@croesoffice.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Matsui |
Organization
Kyoto University
Division name
Faculty of Medicine, the Department of Urology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3337
Homepage URL
ym1108@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
CROES(Clinical Research Office of the Endourological Society)
Institute
Department
Personal name
Funding Source
Organization
CROES(Clinical Research Office of the Endourological Society)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2010-019576-68
Org. issuing International ID_1
EudraCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 11 | Day |
Last modified on
| 2018 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005430
