UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014672 |
|---|---|
| Receipt number | 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 | 2024/02/03 10:43:35 |
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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 | Mitsuhiro |
| Middle name | |
| Last name | Yamada |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
9808574
Address
1-1 Seiryoumachi, Aobaku, Sendai Japan
TEL
022-717-8539
yamitsu@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Yamada |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
9808574
Address
1-1 Seiryoumachi, Aobaku, Sendai Japan
TEL
022-717-8539
Homepage URL
yamitsu@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Mitsuhiro Yamada
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@bureau.tohoku.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
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
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
117
Results
Serum activated endothelium-specific exosomes were analysed in COPD patient samples. No association with stage or prognosis was found.
Results date posted
| 2024 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
117 COPD patients
Participant flow
Serum samples were collected along with patient enrolment and clinical information was collected.
Adverse events
None
Outcome measures
Stage of disease, frequency of exacerbations
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Measurement of serum exosomes.
Management information
Registered date
| 2014 | Year | 07 | Month | 28 | Day |
Last modified on
| 2024 | 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=R000017064
