UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019067 |
|---|---|
| Receipt number | R000022047 |
| Scientific Title | The role of Growth differentiation factor 11 in the pathogenesis of chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2015/09/18 |
| Last modified on | 2020/03/23 17:55:35 |
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Basic information
Public title
The role of Growth differentiation factor 11 in the pathogenesis of chronic obstructive pulmonary disease
Acronym
The role of Growth differentiation factor 11 in the pathogenesis of chronic obstructive pulmonary disease
Scientific Title
The role of Growth differentiation factor 11 in the pathogenesis of chronic obstructive pulmonary disease
Scientific Title:Acronym
The role of Growth differentiation factor 11 in the pathogenesis of chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the expression of GDF11 in lung and blood and to elucidate the role of GDF11 in the cellular senescence of lung fibroblast.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the expression of GDF11 in COPD patients is decreased and whether GDF11 suppress the cellular senescence of human lung fibroblasts
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
Key exclusion criteria
patients and healthy volunteers who deny participating in this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ichikawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
980-8574
Address
1-1 Seiryoumachi, Aobaku, Sendai Japan
TEL
022-717-8539
ichikawa@rm.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ichikawa |
Organization
TohokuUniversityGraduateSchoolof Medicine
Division name
DepartmentofRespiratoryMedicine
Zip code
980-8574
Address
1-1Seiryoumachi,Aobaku,Sendai Japan
TEL
022-717-8539
Homepage URL
ichikawa@rm.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, TohokuUniversityGraduateSchoolof Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Respiratory Medicine
Address
2-1 Seiryoumachi, Aobaku, Sendai 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)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 18 | 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
The levels of GDF11 are decreased in both the plasma and lungs of COPD patients, and inversely correlate with the severity of the airflow limitation; treatment with GDF11 inhibits the cigarette smoke (CSE)-induced cellular senescence and production of inflammatory mediators in vitro.
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
| 2012 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
study design : cohort study
subjects recruitment method : all subjects who admit to our hospital since May 2013 and meet the selection criteria and who apply to pubilic offering.
mesurement items : lung function, lung tissues, blood samples
Management information
Registered date
| 2015 | Year | 09 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022047
