UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032888 |
|---|---|
| Receipt number | R000037494 |
| Scientific Title | Investigation of biomarkers for diagnosis and treatment of pulmonary hypertension. |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2020/06/08 09:53:31 |
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Basic information
Public title
Investigation of biomarkers for diagnosis and treatment of pulmonary hypertension.
Acronym
Biomarkers for pulmonary hypertension.
Scientific Title
Investigation of biomarkers for diagnosis and treatment of pulmonary hypertension.
Scientific Title:Acronym
Biomarkers for pulmonary hypertension.
Region
| Japan |
Condition
Condition
Pulmonary hypertension
Classification by specialty
| Cardiology | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objectives of this study is to establish the biomarkers for early daiagnosis and useful treatment of pulmonary hypertension.
Basic objectives2
Others
Basic objectives -Others
Verification of usefulness of serum periostin and blood - derived exosomes as a biomarker in pulmonary hypertension.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
level of serum periostin.
Profile of microRNA and protein in exosome from blood sample.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who is diagnosed as pulmonary hypertension including from group 1 to 5 in international classification.
Key exclusion criteria
Patient who has not undergone right heart catheterization and has not reached definite diagnosis of pulmonary hypertension.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tetsutaro |
| Middle name | |
| Last name | Nagaoka |
Organization
Juntendo University
Division name
Division of respiratory medicine
Zip code
113-8431
Address
Nerima-ku
TEL
0358021063
jnagaoka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tetsutaro |
| Middle name | |
| Last name | Nagaoka |
Organization
Juntendo University
Division name
Division of respiratory medicine
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1063
Homepage URL
jnagaoka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo university
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
Juntendo University Hospital
Address
3-1-3 Hongo
Tel
+81358021063
jnagaoka@juntendo.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
| 2018 | Year | 07 | 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
| 2018 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We verify the correlation between severity of pulmonary hypertension and biomarkers in each group.
Management information
Registered date
| 2018 | Year | 06 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037494
