UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026638 |
|---|---|
| Receipt number | R000030592 |
| Scientific Title | Role of mast cells and bioactive peptides in the pathogenesis of systemic sclerosis and pulmonary hypertension |
| Date of disclosure of the study information | 2017/03/24 |
| Last modified on | 2019/03/24 14:43:36 |
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Basic information
Public title
Role of mast cells and bioactive peptides in the pathogenesis of systemic sclerosis and pulmonary hypertension
Acronym
Role of mast cells in the pathogenesis of systemic sclerosis
Scientific Title
Role of mast cells and bioactive peptides in the pathogenesis of systemic sclerosis and pulmonary hypertension
Scientific Title:Acronym
Role of mast cells in the pathogenesis of systemic sclerosis
Region
| Japan |
Condition
Condition
systemic sclerosis/pulmonary hypertension
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the expression levels of mast cells and their related serum bioactive peptides and to elucidate the relationship between mast cells and the pathogenesis of systemic sclerosis/pulmonary hypertension
Basic objectives2
Others
Basic objectives -Others
The number of mast cells and the extent of their degranulation in skin lesions of systemic sclerosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of serum levels of ET-1, AT II, VIP, Hsp70, Billycan, HMGB1, and IL-33 in patients with systemic sclerosis and pulmonary hypertension
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with systemic sclerosis, MCTD, and other collagen vascular diseases (complicated with pulmonary hypertension) in Kyushu University Hospital
Key exclusion criteria
None
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Akashi |
Organization
Kyushu University Graduate School of Medicine
Division name
Department of Medicine and Biosystemic Sciences
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-5228
akashi@cancer.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kashiwado |
Organization
Kyushu University Graduate School of Medicine
Division name
Department of Medicine and Biosystemic Sciences
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-5233
Homepage URL
kashiwa@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical and Translational Research (CCTR)
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, 812-8582, Japan
Tel
092-642-5774
stemcell@med.kyushu-u.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research period: April 17, 2014~March 31, 2019
Management information
Registered date
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030592
