UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001313
Receipt number 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 13:56:33

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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 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


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

Value
https://center6.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