UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003279 |
|---|---|
| Receipt number | R000003965 |
| Scientific Title | Appropriate lymph node dissection in bladder cancer and upper urinary tract cancer: a prospective mapping study |
| Date of disclosure of the study information | 2010/03/08 |
| Last modified on | 2010/03/02 21:10:36 |
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Basic information
Public title
Appropriate lymph node dissection in bladder cancer and upper urinary tract cancer: a prospective mapping study
Acronym
Lymph node dissection in bladder cancer and upper urinary tract cancer
Scientific Title
Appropriate lymph node dissection in bladder cancer and upper urinary tract cancer: a prospective mapping study
Scientific Title:Acronym
Lymph node dissection in bladder cancer and upper urinary tract cancer
Region
| Japan |
Condition
Condition
bladder cancer, upper urinary tract cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to determine the incidence as well as location of lymph node metastasis regarding the primary tumor location in urothelial cancer in order to clarify the appropriate lymph node dissection area.
Basic objectives2
Others
Basic objectives -Others
Our aim is to determine the incidence as well as location of lymph node metastasis regarding the primary tumor location in urothelial cancer in order to clarify the appropriate lymph node dissection area.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1 incidence of node metastasis and its location
2 incidence of micrometastasis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 who are going to undergo definitive surgery for
bladder cancer or upper urinary tract cancer at Hokkaido University Hospital, Hokkaido Cancer center or Sapporo City General Hospital are included in this study.
Key exclusion criteria
Patients are excluded with distant metastasis, systemic chemotherapy or radiotherapy
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashige Abe |
Organization
Hokkaido University Hospital
Division name
Department of Urology
Zip code
Address
KIta 14, Nishi 5, Kita-ku, Sapporo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hokkaido University Hospital
Division name
Department of Urology
Zip code
Address
TEL
011-716-1161
Homepage URL
Sponsor or person
Institute
Hokkiado University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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 | 03 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Our aim is to determine the incidence of node disease including micrometastasis in patients with bladder or upper urinary tract cancer. The dissection area is standardized in the participating hospitals.
Management information
Registered date
| 2010 | Year | 03 | Month | 02 | Day |
Last modified on
| 2010 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003965
