UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028091 |
|---|---|
| Receipt number | R000032161 |
| Scientific Title | Clinical investigation for the establishment of predictive marker for therapy-related cardiovascular adverse events onset in hematologic malignancies. |
| Date of disclosure of the study information | 2017/07/06 |
| Last modified on | 2022/08/08 18:26:29 |
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Basic information
Public title
Clinical investigation for the establishment of predictive marker for therapy-related cardiovascular adverse events onset in hematologic malignancies.
Acronym
Relationship between the treatment in hematological malignancies and endothelial progenitor cells (EPC)
Scientific Title
Clinical investigation for the establishment of predictive marker for therapy-related cardiovascular adverse events onset in hematologic malignancies.
Scientific Title:Acronym
Relationship between the treatment in hematological malignancies and endothelial progenitor cells (EPC)
Region
| Japan |
Condition
Condition
hematologic malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes of xanthine oxidase activity and the absolute number of EPC in peripheral blood before and after in each treatment against hematologic malignancies.
Basic objectives2
Others
Basic objectives -Others
Relationship with cardiovascular adverse events onset
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the changes of xanthine oxidase activity, the absolute number of EPC in peripheral blood and the cardiovascular adverse events onset
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
The patients diagnosed with hematologic malignancies and who will be treated by the therapy which can cause cardiovascular adverse events onset at Akita university hospital.
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Kobayashi |
Organization
Akita University Graduate School of Medicine
Division name
Department of Hematology, Nephrology, Rheumatology,
Zip code
Address
1-1-1 Hondo, Akita City, Akita, Japan
TEL
018-884-6116
takahiro@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Kobayashi |
Organization
Akita University Graduate School of Medicine
Division name
Department of Hematology, Nephrology, Rheumatology,
Zip code
Address
1-1-1 Hondo, Akita City, Akita, Japan
TEL
018-884-6116
Homepage URL
takahiro@med.akita-u.ac.jp
Sponsor or person
Institute
Department of Hematology, Nephrology, Rheumatology, Akita University Graduate School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology, Nephrology, Rheumatology, Akita University Graduate School of Medicine.
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
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
| 2017 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the clinical data which can be concerned with cardiovascular adverse events onset for example basic physical information and comorbidities and laboratory abnormalities
Management information
Registered date
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2022 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032161
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
