UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016857 |
|---|---|
| Receipt number | R000019569 |
| Scientific Title | Investigation of pulmonary hypertension in patients receiving tyrosine kinase inhibitors |
| Date of disclosure of the study information | 2015/03/20 |
| Last modified on | 2016/01/18 11:23:55 |
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Basic information
Public title
Investigation of pulmonary hypertension in patients receiving tyrosine kinase inhibitors
Acronym
TKI-induced PH
Scientific Title
Investigation of pulmonary hypertension in patients receiving tyrosine kinase inhibitors
Scientific Title:Acronym
TKI-induced PH
Region
| Japan |
Condition
Condition
Chronic myelogenous leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To assess the incidence and frequency of pulmonary hypertension in CML or Ph-positive ALL patients taking tyrosine kinase inhibitors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of tyrosine kinase inhibitor induced pulmonary hypertension.
Key secondary outcomes
Risk factors associated with tyrosine kinase inhibitor induced pulmonary hypertension.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Tyrosine kinase inhibitor
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 under treatment with TKI at the institutions participating this investigation.
Key exclusion criteria
Unable to obtain the consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Akashi |
Organization
Kyushu University Hospital
Division name
Department of medicine and biosystemic science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926425228
toshmiya@intmed1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Miyamoto |
Organization
Kyushu University Hospital
Division name
Department of medicine and biosystemic science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5230
Homepage URL
toshmiya@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university
Institute
Department
Personal name
Funding Source
Organization
Fukuoka bone marrow transplantation group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 03 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 20 | Day |
Last modified on
| 2016 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019569
