UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Prof Jean de la Rosette
Organization	AMC University Hospital
Division name	the Department of Urology
Address	Meibergdreef 9, 1105 AZ, Amsterdam
TEL	020-566-9111
Email	info@croesoffice.org

Public contact
Name of contact person	Yoshiyuki Matsui
Organization	Kyoto University
Division name	Faculty of Medicine, the Department of Urology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3337
Homepage URL
Email	ym1108@kuhp.kyoto-u.ac.jp

Sponsor
Institute	CROES(Clinical Research Office of the Endourological Society)
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005430