UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003279
Receipt No. 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

* 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 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
Email

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
Email

Sponsor
Institute Hokkiado University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003965

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.