UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047417 |
|---|---|
| Receipt number | R000054073 |
| Scientific Title | Clinicopathological study on the pulmonary vasculopathy and cardiac dysfunction in pulmonary hypertension |
| Date of disclosure of the study information | 2022/04/06 |
| Last modified on | 2024/04/16 15:26:32 |
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Basic information
Public title
Clinicopathological study on the pulmonary vasculopathy and cardiac dysfunction in pulmonary hypertension
Acronym
PHYCS study
Scientific Title
Clinicopathological study on the pulmonary vasculopathy and cardiac dysfunction in pulmonary hypertension
Scientific Title:Acronym
PHYCS study
Region
| Japan |
Condition
Condition
pulmonary hypertension, interstitial lung disease, chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the histopathological features of pulmonary vascular lesions and myocardium in patients with chronic lung disease-associated pulmonary hypertension.
Basic objectives2
Others
Basic objectives -Others
Retrospective study to investigate the clinical and histopathological features of pulmonary hypertension
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area ratio of media and intima of pulmonary muscular arteries
Key secondary outcomes
1. Luminal stenosis rate of pulmonary muscular arteries
2. Distribution density, wall thickening, and stenosis or dilation of pulmonary veins and lymph vessels; the presence and the degree, if present, of capillary lesions
3. Relationship between the degree of pulmonary vascular lesions and background lung lesions (emphysema, fibrosis, etc.)
4. The degree, if present, of pathological changes such as myocardial hypertrophy and fibrosis
5. Histological analysis on the target protein of pulmonary vasodilators in pulmonary blood vessels and myocardium
6. Relationship between the morphological findings and clinical course including the treatment response
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
1. Those in whom the comprehensive consent for research use of specimens was obtained at the time of autopsy from the family member, and the following criteria were met
- Patient group to be studied (Lung-PH group): Those who had been diagnosed with pulmonary hypertension associated with lung disease (Lung-PH) by examinations including right heart catheterization after January 1st, 2001
- Control group 1 (Control group): Those who died after January 1st, 2001 for reasons other than overt cardiopulmonary disease, and the histopathological specimens were stored at the Department of Pathology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University or Department of Cancer Pathology, Faculty of Medicine, Hokkaido University
- Control group 2 (PH group other than Lung-PH): Those who had been diagnosed with PH other than Lung-PH by examinations including right heart catheterization and/or autopsy, and the histopathological specimens were stored at Department of Pathology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University or Department of Cancer Pathology, Faculty of Medicine, Hokkaido University
- Control group 3 (Lung-NoPH group): Those who had been diagnosed with lung disease without PH (interstitial lung disease, chronic obstructive pulmonary disease, etc.) by examinations including echocardiography and/or autopsy, and the histopathological specimens were stored at Department of Pathology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University or Department of Cancer Pathology, Faculty of Medicine, Hokkaido University
2. When the voluntary consent to participate in this study has been obtained from legal representative(s) of the patients including close relative or when there has been no refusal for the participation to the present study.
Key exclusion criteria
Those who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Ichizo |
| Middle name | |
| Last name | Tsujino |
Organization
Hokkaido University
Division name
Department of Respiratory Medicine, Faculty of Medicine
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5911
itsujino@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Ichizo |
| Middle name | |
| Last name | Tsujino |
Organization
Hokkaido University
Division name
Department of Respiratory Medicine, Faculty of Medicine
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5911
Homepage URL
itsujino@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido 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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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 | 06 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We searched for cases in which autopsy was performed after January 1, 2001, and histopathological specimens were stored at Department of Pathology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University or Department of Cancer Pathology, Faculty of Medicine, Hokkaido University (including Obihiro Kosei Hospital for the Lung-PH group), and then we selected the cases that met the selection criteria.
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054073
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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