UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002519 |
|---|---|
| Receipt number | 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 14:57:24 |
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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
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
hara@wakayama-med.ac.jp
Sponsor or person
Institute
Department of Urology, Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003080
