UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003301
Receipt number R000003962
Scientific Title Analysis of efficacy of biochemical markers and the method of the detection of abnormal prion protein in CSF of prio disease patients
Date of disclosure of the study information 2012/03/31
Last modified on 2015/03/27 14:11:12

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Basic information

Public title

Analysis of efficacy of biochemical markers and the method of the detection of abnormal prion protein in CSF of prio disease patients

Acronym

Analysis of efficacy of markers in CSFof prio disease patients

Scientific Title

Analysis of efficacy of biochemical markers and the method of the detection of abnormal prion protein in CSF of prio disease patients

Scientific Title:Acronym

Analysis of efficacy of markers in CSFof prio disease patients

Region

Japan


Condition

Condition

prion disease

Classification by specialty

Medicine in general Neurology Infectious disease
Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Analysis of biochemical makers and Usefulness of the detective method of abnormal prion protein of CSF in prion disease patients

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

the diagnostic markers of prion disease

Key secondary outcomes

the sensitivity and the specificity


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

prion disease patients

Key exclusion criteria

non-prion disease patients

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuya Satoh

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

department of Molecular Microbiology and Immunology

Zip code


Address

1-12-4 Sakamoto, Nagasaki

TEL

095-819-7059

Email

f1537@cc.nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuya Satoh

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Molecular Microbiology and Immunology

Zip code


Address

1-12-4 Sakamoto, Nagasaki

TEL

095-819-7059

Homepage URL


Email

f1537@cc.nagasaki-u.ac.jp


Sponsor or person

Institute

Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2012 Year 03 Month 31 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

We had analyzed for the sensitivity and specificity of biomarkers and RT-QUIC method. We are going to report them by the manuscript in 2015.

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

Open public recruiting

Date of protocol fixation

2010 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date

2014 Year 03 Month 30 Day

Date of closure to data entry

2014 Year 03 Month 30 Day

Date trial data considered complete

2014 Year 03 Month 30 Day

Date analysis concluded

2014 Year 03 Month 30 Day


Other

Other related information

retrospective study to reveal the rate of biochemical marker and the usefulness of the detcteion of abnormal prion protein in CSF of prio disease patients.


Management information

Registered date

2010 Year 03 Month 08 Day

Last modified on

2015 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003962


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name