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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041273
Receipt No. R000047138
Scientific Title A randomized control trial of fluorescence cystoscopy-assisted en bloc transurethral resection and conventional transurethral resection in patients with non-muscle invasive bladder cancer
Date of disclosure of the study information 2020/08/01
Last modified on 2020/08/01

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Basic information
Public title A randomized control trial of fluorescence cystoscopy-assisted en bloc transurethral resection and conventional transurethral resection in patients with non-muscle invasive bladder cancer
Acronym FLEBER study
Scientific Title A randomized control trial of fluorescence cystoscopy-assisted en bloc transurethral resection and conventional transurethral resection in patients with non-muscle invasive bladder cancer
Scientific Title:Acronym FLEBER study
Region
Japan

Condition
Condition Non-muscle invasive bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The evaluation of clinical efficacy and safety of fluorescence cystoscopy-assisted en bloc transurethral resection in patients with non-muscle invasive bladder cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Two-year recurrence-free rate
Key secondary outcomes 1) Recurrence-free survival
2) Progression-free survival and progression-free rate (Progression: Ta to T1 or muscle-invasive disease)
3) Upper urinary tract cancer-free survival
4) Metastasis-free survival
5) Cancer-specific survival
6) Overall survival
7) Operation time
8) Postoperative change of blood hemoglobin level
9) Pathological complete resection rate
10) Postoperative change of urinary frequency at 1, 3, and 6 months after transurethral resection (evaluation with frequency volume chart)
11) Rate of adverse events (evaluation with CTCAE ver 5)
12) Postoperative change of health-related quality of life (evaluation with SF-8, EORTC QLQ-C30, and FACT-BL)
13) Postoperative change of lower urinary tract symptoms (evaluation with IPSS and OABSS)
14) Postoperative pain (evaluation with NPRS, VAS, and FAS)
15) Operative scar at 3 and 6 months after transurethral resection (evaluation with cystoscopy)
16) Influence of tumor location (trigon, posterior wall, dome, anterior wall, right wall, left wall, and bladder neck) in primary and secondary endpoints

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
Maneuver
Interventions/Control_1 Fluorescence cystoscopy-assisted en bloc transurethral resection
Interventions/Control_2 Fluorescence cystoscopy-assisted conventional transurethral resection
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients undergoing fluorescence cystoscopy-assisted transurethral resection of bladder tumor and the tumor size (longer diameter) is 6 mm to 30 mm. In patients with multiple tumors, the largest tumor is evaluated.
2) Clinical stage, TaN0M0 or T1N0M0
3) ECOG-Performance Status : 0 to 2
4) Age, 20 to 85 yo
5) Sufficient bone marrow function and organ functions within 60 days before the registration
Key exclusion criteria 1) Suspected of having carcinoma in situ (CIS)
2) History of allergic reaction to 5-aminolevulinic acid
3) Patients with clinically significant liver dysfucntion and liver inflammation
4) Patients with porphyria
5) Patients who can not agree with enrollment of the study by his/her own intention
6) Inappropriate for the enrolment by the judgement of the physician
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Makito
Middle name
Last name Miyake
Organization Nara Medical University
Division name Urology
Zip code 6348522
Address 840 Shijo-cho, Kashihara, Nara, Japan
TEL 0744-22-3051
Email makitomiyake@naramed-u.ac.jp

Public contact
Name of contact person
1st name Makito
Middle name
Last name Miyake
Organization Nara Medical University
Division name Urology
Zip code 6348522
Address 840 Shijo-cho, Kashihara, Nara, Japan
TEL 0744-22-3051
Homepage URL http://www.naramed-u.ac.jp/~urol/about/theme.html
Email urology@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institute of Clinical and Translational Science, Nara Medical University
Address 840 Shijo-cho, Kashihara, Nara, Japan
Tel 0744-22-3051
Email ethics_nara@naramed-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2020 Year 07 Month 31 Day
Date of IRB
2020 Year 07 Month 31 Day
Anticipated trial start date
2020 Year 08 Month 03 Day
Last follow-up date
2025 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 01 Day
Last modified on
2020 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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