UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038398
Receipt number R000043756
Scientific Title Research for biomarkers in patients with rapidly progressive dementia including human prion disease
Date of disclosure of the study information 2019/11/01
Last modified on 2023/04/29 13:44:08

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Basic information

Public title

Research for biomarkers in patients with rapidly progressive dementia including human prion disease

Acronym

Research for biomarkers in patients with rapidly progressive dementia

Scientific Title

Research for biomarkers in patients with rapidly progressive dementia including human prion disease

Scientific Title:Acronym

Research for biomarkers in patients with rapidly progressive dementia

Region

Japan Asia(except Japan) North America
Australia Europe Africa


Condition

Condition

rapidly progressive dementia including human prion disease

Classification by specialty

Neurology Clinical immunology Infectious disease
Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We clarify a causative agent using living body materials for an intervital patient diagnosed as being progressive rapidly and establish the biomarker and protein detection method.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The sensitivity and specificity of biomarkers among the 1500 cases during three years

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

500 cases per one year
2500 cases forfive years

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 cases suspected rapidly progressive dementia including prion disease

Key exclusion criteria

none

Target sample size

2500


Research contact person

Name of lead principal investigator

1st name Katsuya
Middle name
Last name Satoh

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences

Zip code

852-8501

Address

1-7-1 Sakamoto, Nagasaki City, Japan

TEL

095-819-7991

Email

satoh-prion@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Katsuya
Middle name
Last name Satoh

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences

Zip code

852-8501

Address

1-7-1 Sakamoto, Nagasaki City, Japan

TEL

095-819-7991

Homepage URL

http://www2.am.nagasaki-u.ac.jp/prion-cjd/prion/

Email

satoh-prion@nagasaki-u.ac.jp


Sponsor or person

Institute

Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Nagasaki University Graduate School of Biomedical Sciences

Institute

Department

Personal name



Funding Source

Organization

Research Group on surveillance and infection prevention of prion disease

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Life and Medical Sciences, Research Office, General Affairs Division (Research Support)

Address

1-12-4 Sakamoto, Nagasaki City

Tel

095-819-7198

Email

yoshi-t@nagasaki-u.ac.jp


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

2019 Year 11 Month 01 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

100000

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Because the case goal of 10,000 cases has not been met.

Date of the first journal publication of results


Baseline Characteristics

Patients with rapid dementia including prion disease who were checked by Japan Prion Disease Surveillance Committee

Participant flow

Cases that participated in our study and were checked by the Prion Disease Surveillance Committee

Adverse events

NOne

Outcome measures

Sensitivity and specificity in biomarkers for patients with rapidly progressive dementia

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2019 Year 10 Month 01 Day

Date of IRB

2019 Year 10 Month 01 Day

Anticipated trial start date

2019 Year 10 Month 25 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry

2026 Year 03 Month 31 Day

Date trial data considered complete

2026 Year 03 Month 31 Day

Date analysis concluded

2027 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 10 Month 27 Day

Last modified on

2023 Year 04 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043756


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name