UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053641 |
|---|---|
| Receipt number | R000056907 |
| Scientific Title | Japan Tumoral Pulmonary Hypertension Registry |
| Date of disclosure of the study information | 2024/02/20 |
| Last modified on | 2024/02/22 10:28:59 |
* 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
Japan Tumoral Pulmonary Hypertension Registry
Acronym
Japan Tumoral Pulmonary Hypertension Registry
Scientific Title
Japan Tumoral Pulmonary Hypertension Registry
Scientific Title:Acronym
Japan Tumoral Pulmonary Hypertension Registry
Region
| Japan |
Condition
Condition
Tumoral Pulmonary Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the database, and evaluate the prevalence, clinical features and prognosis of of tumoral pulmonary hypertension.
Basic objectives2
Others
Basic objectives -Others
Evaluation of clinical features, treatment and prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
epidemiology
prognosis
diagnosis/treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Pulmonary hypertension (mean pulmonary artery pressure over 20 mmHg by right heart catheterization or RVSP over 40 mmHg by echocardiography)
2)cancer (diagnosed or suspected)
3)age: 18 year-old and over
4)sex:both
Key exclusion criteria
1)age: under 18 year-old
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Hatano |
Organization
The University of Tokyo
Division name
Department of Advanced Medical Center for Heart Failure/ Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
hatanoma@pg8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Shimbo |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine/Computational Diagnostic Radiology and Preventive Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
shimbom-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
Masaru Hatano
Institute
Department
Personal name
Funding Source
Organization
Japanese College of Cardiology
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
The University of Tokyo, Research Review Board
Address
7-3-1, Hongo,Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2024 | Year | 02 | 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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2029 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multi-center study.
Management information
Registered date
| 2024 | Year | 02 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056907
