UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018932
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hirobets@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University, Department of Urology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018532

Research Plan
Registered date File name

Research case data specifications
Registered date File name
2016/03/31 UMINへの追加登録ファイル.xlsx

Research case data
Registered date File name


Contact us.