UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023209 |
|---|---|
| Receipt number | R000026755 |
| Scientific Title | The investigation of anticancer drug-induced cardiomyopathy |
| Date of disclosure of the study information | 2016/08/16 |
| Last modified on | 2025/10/17 11:58:07 |
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Basic information
Public title
The investigation of anticancer drug-induced cardiomyopathy
Acronym
The investigation of anticancer drug-induced cardiomyopathy
Scientific Title
The investigation of anticancer drug-induced cardiomyopathy
Scientific Title:Acronym
The investigation of anticancer drug-induced cardiomyopathy
Region
| Japan |
Condition
Condition
Drug-induced cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the frequency, severity, and the extent of DNA damage in the patients with anticancer drug-induced cardiomyopathy.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation of cardiac function by using echocardiography, cardiac MRI
Key secondary outcomes
The evaluation of the severity of double-strand breaks of DNA in mononuclear cells
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Cancer patients scheduled for chemotherapy by using cardiotoxic drugs
2) Cancer patients with the history of using cardiotoxic drugs
3) Patients can provide informed consent
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Oikawa |
Organization
Fukushima Medical University
Division name
Department of Cardiovascular Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima-shi, Fukushima prefecture, Japan
TEL
024-547-1190
takeishi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Oikawa |
Organization
Fukushima Medical University
Division name
Department of Cardiovascular Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima-shi, Fukushima prefecture, Japan
TEL
024-547-1190
Homepage URL
moikawa@fmu.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Fukushima Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1-Hikarigaoka, Fukushima-shi, Fukushima, Japan
Tel
024-547-1825
rs@fmu.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
福島県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
800
Results
We enrolled 1200 patients in this study. Those patients are still under observation period, and the final analysis is not performed yet.
Results date posted
| 2021 | Year | 09 | Month | 05 | Day |
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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026755
