UMIN-CTR Clinical Trial
| Recruitment status | Open public recruiting |
| Unique ID issued by UMIN | UMIN000019067 |
| Receipt No. | 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 (Ver. 6) |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
| 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 |
|
|
| Condition | ||
| Condition | chronic obstructive pulmonary disease (COPD) | |
| Classification by specialty |
|
|
| 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 |
|
|||
| Age-upper limit |
|
|||
| 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 |
|
||||||
| 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 |
|
||||||
| 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 | |
| Institute | Department of Respiratory Medicine, TohokuUniversityGraduateSchoolof Medicine |
| Institute | |
| Department | |
| 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 |
|
||||||
| 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 |
|
||||||
| Date of IRB | |||||||
| Anticipated trial start date |
|
||||||
| 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 |
|
||||||
| Last modified on |
|
||||||
| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022047 |
