UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001940 |
|---|---|
| Receipt number | 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 19:27:17 |
* 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
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
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
tkondo@kc.twmu.ac.jp
Sponsor or person
Institute
Department of Urology, Tokyo Women's Medical Univerity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002361
