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Recruitment status Terminated
Unique ID issued by UMIN UMIN000001313
Receipt No. R000001596
Scientific Title Clinical significance of novel urinary markers for the diagnosis, staging, and the prediction of prognosis in patients with prostate cancer
Date of disclosure of the study information 2008/08/14
Last modified on 2009/06/28

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Basic information
Public title Clinical significance of novel urinary markers for the diagnosis, staging, and the prediction of prognosis in patients with prostate cancer
Acronym Clinical significance of novel urinary markers in prostate cancer
Scientific Title Clinical significance of novel urinary markers for the diagnosis, staging, and the prediction of prognosis in patients with prostate cancer
Scientific Title:Acronym Clinical significance of novel urinary markers in prostate cancer
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It would be economically of great benefit to find predictors for prostate cancer diagnosis, staging, and prognosis more accurately. The aim of our study is to evaluate the utility of urinary marker such as PCA3, PSA-related marker, and AMACR for improving prostate cancer diagnosis, staging, and prediction of prognosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the association between urinary markers and 1)presence or absence of prostate cancer, 2)cinical staging, 3)pathological staging (TNM clasification), 4)PSA recurrence, and 5)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
30 years-old <=
Age-upper limit
100 years-old >
Gender Male
Key inclusion criteria The patients who undergo needle biopsy of the prostate and the patients who diagnosed as prostate cancer
Key exclusion criteria The patients who do not have anus because prostate massage is not possible during the procedure to get samples
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 03-5363-3825
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
2008 Year 08 Month 14 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 Terminated
Date of protocol fixation
2008 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information Case control sampling and prospective study

Management information
Registered date
2008 Year 08 Month 13 Day
Last modified on
2009 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001596

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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