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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001940
Receipt No. R000002361
Scientific Title A study of the survival benefit of lymphadenectomy with radical surgery for the patients with urothelial carcinoma - A prospective study of extended lymphadenectomy-
Date of disclosure of the study information 2010/04/01
Last modified on 2012/11/03

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Basic information
Public title A study of the survival benefit of lymphadenectomy with radical surgery for the patients with urothelial carcinoma
- A prospective study of extended lymphadenectomy-
Acronym A prospective study of lymphadenectomy for urothelial carcinoma of the upper urinary tract
Scientific Title A study of the survival benefit of lymphadenectomy with radical surgery for the patients with urothelial carcinoma
- A prospective study of extended lymphadenectomy-
Scientific Title:Acronym A prospective study of lymphadenectomy for urothelial carcinoma of the upper urinary tract
Region
Japan

Condition
Condition urothelial carcinoma of the upper urinary tract
urothelial carcinoma of the bladder
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The survival benefit of extended lymphadenectomy has been retrospectively reported. In this study, we prospectively analyze the benefical effect of lymphadenectomy with the template of LND which is determined in advance based on our retrospective study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes cancer-specific survival
Key secondary outcomes intravesical recurrence
disease-free survival
overall survival

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
Maneuver
Interventions/Control_1 extended lymphadenectomy (complete dissection of regional lymph nodes)
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria the patients without severe co-mobidity, with urothelial carcinoma and without distant metastasis
Key exclusion criteria the patients considered inelegible for this study
the patients with non-urothelial carcinoma
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunari Tanabe
Organization Tokyo Women's Medical Universtiy
Division name Urology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsunenori Kondo
Organization Tokyo Women's Medical University
Division name Urology
Zip code
Address
TEL
Homepage URL
Email tkondo@kc.twmu.ac.jp

Sponsor
Institute Department of Urology, Tokyo Women's Medical Univerity
Institute
Department

Funding Source
Organization none
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

Other administrative information
Date of disclosure of the study information
2010 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
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 Open public recruiting
Date of protocol fixation
2004 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 01 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 03 Day
Last modified on
2012 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002361

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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