UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039828 |
|---|---|
| Receipt number | R000045419 |
| Scientific Title | Comprehensive analysis of biomarkers in patients with pulmonary arterial hypertension |
| Date of disclosure of the study information | 2020/03/16 |
| Last modified on | 2022/01/11 15:21:23 |
* 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
Comprehensive analysis of biomarkers in patients with pulmonary arterial hypertension
Acronym
Comprehensive analysis of biomarkers in patients with pulmonary arterial hypertension
Scientific Title
Comprehensive analysis of biomarkers in patients with pulmonary arterial hypertension
Scientific Title:Acronym
Comprehensive analysis of biomarkers in patients with pulmonary arterial hypertension
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension
Classification by specialty
| Cardiology | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of Immune-responsive phenotyp
Basic objectives2
Others
Basic objectives -Others
Immune-responsive phenotype threshold
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of Immune-responsive phenotyp
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 pulmonary arterial pulmonary hypertension registered or scheduled to be registered in JAPHR
Key exclusion criteria
Patients who have received biologics within 3 months before blood collection for this study
Patients who withdrew consent to participate in JAPHR Patients who refused to participate in this study
Judged by the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Tamura |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Cardiovascular internal medicine
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku Tokyo
TEL
03-3451-8121
u1@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Tamura |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Cardiovascular internal medicine
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku Tokyo
TEL
03-3451-8121
Homepage URL
u1@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University
Nippon Medical School
Kyusyu University
Kyorin University
Kobe University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare, Mita Hospital
Address
1-4-3 Mita, Minato-ku Tokyo, 108-832
Tel
03-3451-8121
soumu-mita.hosp@iuhw.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
| 2020 | Year | 03 | Month | 16 | 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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation
Year of birth, sex, height, weight, presence or absence of pregnancy, date of diagnosis of pulmonary hypertension, NYHA classification, etiology, 6MWT, PRO index, hemodynamic measurements, respiratory function test, electrocardiogram rhythm, blood test, thyroid function Abnormalities, PH / PAH specific treatments, anticancer drugs, clinical events, clinical events
Biomarker
Blood collection 5ml
Management information
Registered date
| 2020 | Year | 03 | Month | 16 | Day |
Last modified on
| 2022 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045419
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
