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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014672
Receipt No. R000017064
Scientific Title Identification of new biomarkers by analyses of exosomes derived from activated endothlial cells
Date of disclosure of the study information 2014/08/01
Last modified on 2016/07/29

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Basic information
Public title Identification of new biomarkers by analyses of exosomes derived from activated endothlial cells
Acronym Changes in exosomes derived from activated endothelial cells in COPD patients
Scientific Title Identification of new biomarkers by analyses of exosomes derived from activated endothlial cells
Scientific Title:Acronym Changes in exosomes derived from activated endothelial cells in COPD patients
Region
Japan

Condition
Condition chronic obstructive pulmonary disease (COPD):stable phase and acute exacerbation,
interstitial pneumonia(IP)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate if the exosomes including the exosomes derived from activated endothelial cells is prognosis factor for acute excerbation in COPD patients or IP patients
Basic objectives2 Others
Basic objectives -Others observational study
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Changes in circulating exosomes derived from activated endothelial cells at a stable or an acute exacerbation phase of COPD patients or IP patients.
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

Not applicable
Gender Male and Female
Key inclusion criteria COPD patients diagnosed by spirometry and healthy volunteers
IP patients who was diagnosed according to the ATS/ERS statement.
Key exclusion criteria patients and healthy volunteers who deny participating in this study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Yamada
Organization Tohoku University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-1 Seiryoumachi, Aobaku, Sendai Japan
TEL 022-717-8539
Email yamitsu@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiro Yamada
Organization Tohoku University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-1 Seiryoumachi, Aobaku, Sendai Japan
TEL 022-717-8539
Homepage URL
Email yamitsu@med.tohoku.ac.jp

Sponsor
Institute Department of Respiratory Medicine,
Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japanese Red-Cross Ishinomaki Hospital
Hikarigaoka Spellman Hospital
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 東北大学大学院医学系研究科(宮城県)、石巻赤十字病院(宮城県)、光が丘スペルマン病院(宮城県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood samples

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2016 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017064

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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