UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035176 |
|---|---|
| Receipt number | R000040034 |
| Scientific Title | prospective study of whether residual urine volume will affect adverse events of BCG instillation therapy for non-muscle invasive bladder cancer |
| Date of disclosure of the study information | 2018/12/10 |
| Last modified on | 2023/06/13 21:40:01 |
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Basic information
Public title
prospective study of whether residual urine volume will affect adverse events of BCG instillation therapy for non-muscle invasive bladder cancer
Acronym
prospective study of whether residual urine volume will affect adverse events of BCG instillation therapy for non-muscle invasive bladder cancer
Scientific Title
prospective study of whether residual urine volume will affect adverse events of BCG instillation therapy for non-muscle invasive bladder cancer
Scientific Title:Acronym
prospective study of whether residual urine volume will affect adverse events of BCG instillation therapy for non-muscle invasive bladder cancer
Region
| Japan |
Condition
Condition
non-muscle invasive bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Optimization of BCG intravesical injection therapy for non-muscle invasive bladder cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary end point was adverse events and quality of life during enforcement.
We assessed QOL using the EORTC QLQ-C30 before start of BCG, after completion or dropout.
Key secondary outcomes
The secondary endpoints are complications, enforcement frequency and recurrence.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with non-muscle invasive bladder cancer
1)Age: over 20 years old, gender does not matter
2)Patients with ECOG PS 0 or 1
3)Patients who are expected to survive for more than 2 years
4)Patient with document informed consent
5)Patients who are not taking other treatments for bladder cancer
Key exclusion criteria
1)The case with serious complications
2)The case with active double cancer
3)The case with pregnancy,lactation or possibility of pregnancy
4)The case with drug allergy for BCG
5)The case with History of HIV infection, patients with active chronic hepatitis by hepatitis B or C virus
6)Patients with active infection (grade 3 or higher according to CTCAE Version 4.0)
7)The case without the selection criteria
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Obara |
Organization
Iwate Medical University
Division name
Urology
Zip code
0200023
Address
19-1 Uchimaru,Morioka,Iwate
TEL
0196515111
watao@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Kato |
Organization
Iwate Medical University
Division name
Urology
Zip code
0200023
Address
19-1 Uchimaru,Morioka,Iwate
TEL
0196515111
Homepage URL
j2c789@bma.biglobe.ne.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
iwate medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
iwate medical university
Address
19-1 Uchimaru,Morioka,Iwate
Tel
0196515111
d199212k@gmail.com
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
| 2018 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://journals.sagepub.com/eprint/RITKHGZ58MDZTKISP2ZC/full
Publication of results
Partially published
Result
URL related to results and publications
https://journals.sagepub.com/eprint/RITKHGZ58MDZTKISP2ZC/full
Number of participants that the trial has enrolled
69
Results
43 patients were in the SPVR group and 26 patients were in the LPVR group.
In the QOL analyses, cognitive function and emotional function in the functional scale and fatigue, nausea/vomiting, and dyspnoea in the symptomatic scale were worse in the SPVR group than in the LPVR group. In the multivariate analysis, fatigue was worse in the SPVR group than in the LPVR group.
Results date posted
| 2022 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
69 patients were analysed .57 male and 12 female,mean age, 72.7 years.
Participant flow
The EORTC QLQ-C30 scores for all patients in this study and IPSS scores for some patients who received IPSS analysis were assessed before and after BCG instillation therapy. Patients who dropped out because of an adverse event were assessed the day of withdrawal.
Adverse events
Hematuria, pain
Outcome measures
EORTCQLQ-C30,IPSS,post voiding residual volume
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Self-urination finished before administration of BCG.
Urine discharged at the time of urethral catheterization is measured every time as residual urine.
We assessed QOL using the EORTC QLQ-C30 before start of BCG, after completion or dropout.
Management information
Registered date
| 2018 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040034
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