UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039043 |
|---|---|
| Receipt number | R000044523 |
| Scientific Title | Investigation for intravesical recurrences between with and without BCG therapies according to history of therapeutic agents for dysuria in Non-muscle invasive bladder cancer |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2020/01/02 16:22:38 |
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Basic information
Public title
Investigation for intravesical recurrences between with and without BCG therapies according to history of therapeutic agents for dysuria in Non-muscle invasive bladder cancer
Acronym
Investigation for intravesical recurrences between with and without BCG therapies according to history of therapeutic agents for dysuria in Non-muscle invasive bladder cancer
Scientific Title
Investigation for intravesical recurrences between with and without BCG therapies according to history of therapeutic agents for dysuria in Non-muscle invasive bladder cancer
Scientific Title:Acronym
Investigation for intravesical recurrences between with and without BCG therapies according to history of therapeutic agents for dysuria in 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
This study is to investigate the status of therapeutic agents for dysuria and recurrence in Non-muscle invasive bladder cancer (NMIBC) two groups between non-BCG therapy and BCG therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age: 20 years or older, regardless of gender.
2) Urothelial carcinoma who became T1 or less by TUR-BT
3) ECOG PS 0 or 1
4) Expected to survive for more than 2 years
5) Patients who have given written informed consent prior to enrollment in this study
6) Patients who have not received other treatments for bladder cancer (immunotherapy, chemotherapy, molecular targeted therapy, investigational drugs)
7) Cases without serious organ complications in heart, lung, liver, kidney, etc.
Key exclusion criteria
1) HIV infection or active chronic hepatitis
2) Active infection (grade 3 or higher according to CTCAE Version 4.0)
3) The cases judged by doctors to be inappropriate.
Target sample size
200
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
028-3695
Address
2-1-1 Idai-dori Yhaba Shiwa, Iwate
TEL
+81196137111
ikyoku@urology-imu.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Kato |
Organization
Iwate Medical University
Division name
Urology
Zip code
028-3695
Address
2-1-1 Idai-dori Yhaba Shiwa, Iwate
TEL
019-613-7111
Homepage URL
ikyoku@urology-imu.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
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
Iwate Medical University
Address
2-1-1 Idai-dori Yhaba Shiwa, Iwate
Tel
+81196137111
katoyooo@iwate-med.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 | 09 | Month | 30 | 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 | 01 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No paticularity
Management information
Registered date
| 2020 | Year | 01 | Month | 02 | Day |
Last modified on
| 2020 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044523
