UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003858 |
|---|---|
| Receipt number | R000004614 |
| Scientific Title | Clinical significance of bladder biopsies in patients with bladder cancer |
| Date of disclosure of the study information | 2010/07/03 |
| Last modified on | 2011/01/20 14:50:46 |
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Basic information
Public title
Clinical significance of bladder biopsies in patients with bladder cancer
Acronym
Clinical significance of bladder biopsies in patients with bladder cancer
Scientific Title
Clinical significance of bladder biopsies in patients with bladder cancer
Scientific Title:Acronym
Clinical significance of bladder biopsies in patients with bladder cancer
Region
| Japan |
Condition
Condition
Blader cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There seems to be no consensus in patients with bladder cancer taking bladder biopsies during transurethral resection of bladder tumor (TUR-BT) in patients with bladder cancer. The aim of our present study is to investigate results of bladder biopsies retrospectively, and to clarify the indication of bladder biopsies in patients with bladder cancer more accurately.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association between bladder biopsies and 1) presence or absence of bladder carcinoma, 2) pathological staging, 3) recurrence, 4) prognosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with non-muscle invasive bladder cancer treated with TUR-BT who also underwent a bladder biopsy.
Key exclusion criteria
The patients who did not agree with the purpose of this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Kikuchi |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine
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 | 07 | Month | 03 | 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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Retrospective study
Management information
Registered date
| 2010 | Year | 07 | Month | 02 | Day |
Last modified on
| 2011 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004614
