UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018932 |
|---|---|
| Receipt number | R000018532 |
| Scientific Title | Evaluation of diagnostic test for the superficial bladder cancer based intravesical instillation of pirarubicin (THP) prior to transurethral resection (TUR) |
| Date of disclosure of the study information | 2015/09/07 |
| Last modified on | 2016/03/31 21:28:57 |
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Basic information
Public title
Evaluation of diagnostic test for the superficial bladder cancer based intravesical instillation of pirarubicin (THP) prior to transurethral resection (TUR)
Acronym
The significance of intravesical instillation of pirarubicin (THP) for preoperative superficial bladder cancer
Scientific Title
Evaluation of diagnostic test for the superficial bladder cancer based intravesical instillation of pirarubicin (THP) prior to transurethral resection (TUR)
Scientific Title:Acronym
The significance of intravesical instillation of pirarubicin (THP) for preoperative superficial bladder cancer
Region
| Japan |
Condition
Condition
Superficial bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To perform comparative examination between the THP taken lesions and cancerous lesions
Basic objectives2
Others
Basic objectives -Others
To confirm whether THP taken cancerous lesions is advantageous for avoiding the recurrence than THP untaken cancerous lesions
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We study to confirm a tendency whether superficial bladder cancer has take THP, and present whether this finding useful for determining a cancerous lesion. For preparation, we inject THP15mg and distilled water 15ml to urinary bladder 30 minitues before for operation.
We also perform comperative examination among THP taken lesions, lesions by white light and lesions by NBI histopathologically.
Key secondary outcomes
To evaluate the recurrence rate between THP taken lesions and its untaken lesions at 6, 12 months later from last THP injection date for adjuvant therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We inject THP30mg to the urinary bladder for every other week to achieve 8 times as adjuvant therapy. After injections, we observe the bladder cancer recurrence rate between THP taken lesions and THP untaken lesions at 6,12 months later from last THP injection.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
superficial cancer
Key exclusion criteria
progressive cancer
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironori Betsunoh |
Organization
Dokkyo Medical University
Division name
Urology
Zip code
Address
880Kitakobayashi Mibu, Shimotsuga Tochigi 321-0293 JAPAN
TEL
0282872162
hirobets@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Betsunoh |
Organization
Dokkyo Medical University
Division name
Urology
Zip code
Address
880Kitakobayashi Mibu, Shimotsuga Tochigi 321-0293 JAPAN
TEL
0282872162
Homepage URL
hirobets@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University, Department of Urology
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University, Department of Urology
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
Address
Tel
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
獨協医科大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 07 | 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
| 2013 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 07 | Day |
Last modified on
| 2016 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018532
