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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003858
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Urology, Keio University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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