UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052015 |
|---|---|
| Receipt number | R000059377 |
| Scientific Title | Quantitative evaluation of chest CT and prognostic factors for pulmonary hypertension associated with respiratory disease (JAPHR group 3 PH registry) |
| Date of disclosure of the study information | 2023/09/04 |
| Last modified on | 2025/08/30 14:05:27 |
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Basic information
Public title
Analysis of Chest CT in pulmonary hypertension patients associated with respiratory diseases
Acronym
Analysis of Chest CT in pulmonary hypertension patients associated with respiratory diseases
Scientific Title
Quantitative evaluation of chest CT and prognostic factors for pulmonary hypertension associated with respiratory disease (JAPHR group 3 PH registry)
Scientific Title:Acronym
JAPHR group3 PH CT study
Region
| Japan |
Condition
Condition
pulmonary hypertension associated with respiratory diseases (group 3 pulmonary hypertension)
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between chest CT parameters and prognosis / treatment response
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
correlation between chest CT parameters and prognosis / treatment response
Key secondary outcomes
correlation between chest CT parameters and other clinical parameters
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 who were registered for JAPHR group 3 registry with written informed consent
Key exclusion criteria
Exclusion criteria:
Patients who denied to be enrolled for this study
Patients with any condition judged as not eligible for the study by investigators
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Tanabe |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Respirology
Zip code
260-8670
Address
Inohana 1-8-1, Chuo-Ku, Chiba City, Chiba
TEL
043-222-7171
ntanabe@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Naito |
Organization
Chiba University Hospital
Division name
Respirology
Zip code
260-8670
Address
Inohana 1-8-1, Chuo-Ku, Chiba City, Chiba
TEL
043-222-7171
Homepage URL
akira-n.390@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Nobuhiro Tanabe
Funding Source
Organization
None
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
Ethics Committee for Observational Studies of Chiba University Hospital
Address
Inohana 1-8-1, Chuo-Ku, Chiba City, Chiba
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
JR東京総合病院 呼吸器内科
京都大学大学院医学研究科 呼吸不全先進医療学講座
杏林大学医学部 循環器内科学
近畿大学医学部 呼吸器・アレルギー内科
高知大学 医学部附属病院 老年病科・循環器内科
神戸大学大学院医学研究院 循環器内科学
公立陶生病院 呼吸器・アレルギー疾患内科
国際医療福祉大学成田病院 循環器内科
国際医療福祉大学三田病院 循環器内科
国立病院機構茨城東病院 胸部疾患・療育医療センター
国立病院機構岡山医療センター 循環器内科
国立病院機構近畿中央呼吸器センター
国立病院機構東京病院 呼吸器内科
神鋼記念病院 循環器内科
順天堂大学医学部附属順天堂医院 呼吸器内科
信州大学 医学部内科学第一教室
千葉県済生会習志野病院 肺高血圧症センター
千葉大学医学部附属病院 呼吸器内科
東海大学医学部付属病院 呼吸器内科
東海大学医学部付属八王子病院 呼吸器内科
東北大学 循環器内科
日本医科大学附属病院 リウマチ・膠原病内科
日本赤十字社長野赤十字病院 呼吸器内科
福岡大学病院 呼吸器内科
北海道大学大学院医学研究院 呼吸・循環イノベーティブリサーチ分野
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 04 | 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
400
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
| 2023 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
For the patients enrolled for JAPHR group3 regsistry until 31st March 2023,
We will analyze the Chest CT and the clinical data / prognosis until the approval date of this study
Management information
Registered date
| 2023 | Year | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059377
