UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048498
Receipt number R000055223
Scientific Title Proteomics and pathological analysis of human brain samples
Date of disclosure of the study information 2022/07/31
Last modified on 2023/02/03 13:29:12

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Basic information

Public title

Proteomics and pathological analysis of human brain samples

Acronym

Proteomics

Scientific Title

Proteomics and pathological analysis of human brain samples

Scientific Title:Acronym

Proteomics and pathological analysis

Region

Japan


Condition

Condition

Alzheimer's disease, tauopathy, Neurodegenerative disorders

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will conduct proteomic analysis, histopathological examination, and development and evaluation of molecular markers to visualize astrocyte function in human brain tissue.

Basic objectives2

Others

Basic objectives -Others

To explore the molecular mechanisms that influence astrocyte dysfunction associated with dementia pathology and to identify astrocyte functional molecules that are linked to the onset of dementia.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of variable protein groups in human brain diseases by proteome analysis, and their expression profiles. Quantitative and spatial expression distribution of variable protein groups by histopathology. The amount and distribution of binding sites of radiolabeled drugs as candidate molecular markers by autoradiography.

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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Pathological diagnosis

Key exclusion criteria

Fulfill pathological diagnoses other than those of the diseases covered in the current study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yuhei
Middle name
Last name Takado

Organization

National Institutes for Quantum Science and Technology

Division name

Institute for Quantum Medical Science

Zip code

263-8555

Address

4-9-1 Anagawa, Inage-ku

TEL

0432063251

Email

takado.yuhei@qst.go.jp


Public contact

Name of contact person

1st name Yuhei
Middle name
Last name Takado

Organization

National Institutes for Quantum Science and Technology

Division name

Institute for Quantum Medical Science

Zip code

263-8555

Address

4-9-1 Anagawa, Inage-ku

TEL

0432063251

Homepage URL


Email

takado.yuhei@qst.go.jp


Sponsor or person

Institute

National Institutes for Quantum Science and Technology

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

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

National Institutes for Quantum Science and Technology

Address

4-9-1 Anagawa, Inage-ku

Tel

043-206-4706

Email

helsinki@qst.go.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

2022 Year 07 Month 31 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

No longer recruiting

Date of protocol fixation

2022 Year 07 Month 13 Day

Date of IRB

2022 Year 07 Month 14 Day

Anticipated trial start date

2022 Year 08 Month 15 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2022 Year 07 Month 28 Day

Last modified on

2023 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055223


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name