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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043678
Receipt No. R000049344
Scientific Title intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/19

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Basic information
Public title intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Acronym intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Scientific Title intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Scientific Title:Acronym intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Region
Japan

Condition
Condition urothelial carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 efficacy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intravesical recurrence free survival rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 THP intravesical intrusion
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 Upper urinary tract cancer
Key exclusion criteria patients with bladder cancer
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Masumori
Organization Sapporo Medical University School of Medicine
Division name Department of Urology
Zip code 0608543
Address chuo-ku, S1W16, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email masumori@sapmed.ac.jp

Public contact
Name of contact person
1st name Ko
Middle name
Last name Kobayashi
Organization Sapporo Medical University School of Medicine
Division name Department of Urology
Zip code 0608543
Address chuo-ku, S1W16, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email kou@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine, Department of Urology
Institute
Department

Funding Source
Organization none
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 Sapporo Medical University, School of Medicine
Address chuo-ku, S1W16, Sapporo, Hokkaido, Japan
Tel 011-611-2111
Email ji-rskk@sapmed.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
2021 Year 04 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 22
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 No longer recruiting
Date of protocol fixation
2014 Year 07 Month 18 Day
Date of IRB
2014 Year 07 Month 18 Day
Anticipated trial start date
2014 Year 07 Month 18 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 19 Day
Last modified on
2021 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049344

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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