UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041273 |
|---|---|
| Receipt number | 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 | 2025/02/05 11:54:46 |
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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
200
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
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
urology@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
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
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047138
