UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047520 |
|---|---|
| Receipt number | R000054195 |
| Scientific Title | The prospective observational study of tissue characterization and information of genome and gene in patients with chronic thromboembolic pulmonary hypertension |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2022/04/18 23:12:41 |
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Basic information
Public title
The prospective observational study of tissue characterization and information of genome and gene in patients with chronic thromboembolic pulmonary hypertension
Acronym
Pulmonary artery intima analysis
Scientific Title
The prospective observational study of tissue characterization and information of genome and gene in patients with chronic thromboembolic pulmonary hypertension
Scientific Title:Acronym
Analysis of pulmonary artery intima by single cell RNA sequencing
Region
| Japan |
Condition
Condition
Chronic thromboembolic pulmonary hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the characterization of pulmonary artery intima and organized thrombus by single-cell RNA sequencing
Basic objectives2
Others
Basic objectives -Others
Examine contributing factors in chronic thromboembolic pulmonary hypertension by comparing
characterization of pulmonary artery intima and organized thrombus with thrombosis risk.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of single cell gene expression of the pulmonary artery intima and organized thrombus in patients with chronic thromboembolic pulmonary hypertension undergoing pulmonary endarterectomy.
Key secondary outcomes
Relationship between various data of pulmonary artery intima and data of blood sample in patients with chronic thromboembolic pulmonary hypertension undergoing pulmonary endarterectomy.
1. bulk RNA sequencing
2. exosome analysis
3. histological evaluation
4. single cell ATAC sequencing
5. single cell RNA sequencing of blood sample
6. exosome analysis of blood sample
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
(1) Patients who is undergoing pulmonary endarterectomy for Chronic thromboembolic pulmonary hypertension.
(2) patients 20 years of age or older when we get consent form.
(3) Patients for whom written consent has been obtained by the individual.
Key exclusion criteria
(1) Patients suffering from hepatitis B and C viruses and human immunodeficiency virus.
(2) Other patients who are deemed inappropriate by the physician in charge of the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Taniguchi |
Organization
Kobe University Hospital
Division name
The division of Cardiovascular medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Kobe, Hyogo, Japan
TEL
078-382-5846
yu.taniguchi007@gmail.com
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Taniguchi |
Organization
Kobe University Hospital
Division name
The division of Cardiovascular medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Kobe, Hyogo, Japan
TEL
078-382-5846
Homepage URL
yu.taniguchi007@gmail.com
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital/Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital
Address
7-5-2, Kusunoki-cho, Kobe, Hyogo, Japan
Tel
078-382-5111
chiken@med.kobe-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
| 2022 | Year | 04 | Month | 20 | 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
| 2021 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2022 | Year | 04 | Month | 18 | Day |
Last modified on
| 2022 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054195
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| Registered date | File name |
| Research case data | |
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