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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002519
Receipt No. R000003080
Scientific Title The usefulness of extended lymphadenectomy and molecular staging for urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy
Date of disclosure of the study information 2009/09/24
Last modified on 2018/06/01

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Basic information
Public title The usefulness of extended lymphadenectomy and molecular staging for urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy
Acronym The usefulness of extended lymphadenectomy and molecular staging for urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy
Scientific Title The usefulness of extended lymphadenectomy and molecular staging for urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy
Scientific Title:Acronym The usefulness of extended lymphadenectomy and molecular staging for urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy
Region
Japan

Condition
Condition Urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We examine whether extended lymphadenectomy for urothelical carcinoma can improve survival or not. We also investigate the usefulness of molecular staging using RT-PCR for removed lymph nodes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Disease specific survival
Prognostic factor of molecular staging using RT-PCR method

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
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 Urothelial carcinoma patients who undergo nephroureterectomy or total cystectomy , had written informed consent
Key exclusion criteria No informed consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Hara
Organization Wakayama Medical University
Division name Urology
Zip code
Address 811-1 KImiidera, Wakayama, Japan
TEL 073-441-0637
Email hara@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isco Hara, M.D.
Organization Wakayama Medical University
Division name Urology
Zip code
Address 811-1 KImiidera, Wakayama, Japan
TEL 073-441-0637
Homepage URL
Email hara@wakayama-med.ac.jp

Sponsor
Institute Department of Urology, Wakayama Medical University
Institute
Department

Funding Source
Organization Department of Urology, Wakayama Medical University
Organization
Division
Category of Funding Organization Local Government
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 和歌山県立医科大学(和歌山県)
東京女子医科大学(東京都)
市立岸和田市民病院(大阪府)
市立泉佐野病院(大阪府)
国立病院機構大阪南医療センター(和歌山県)
和歌山労災病院(和歌山県)
社会保険紀南病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
2017 Year 07 Month 01 Day
Date trial data considered complete
2017 Year 09 Month 01 Day
Date analysis concluded
2017 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 17 Day
Last modified on
2018 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003080

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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