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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023209
Receipt No. R000026755
Scientific Title The investigation of anticancer drug-induced cardiomyopathy
Date of disclosure of the study information 2016/08/16
Last modified on 2019/08/09

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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 600

Research contact person
Name of lead principal investigator
1st name Yasuchika
Middle name
Last name Takeishi
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
Email 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
Email moikawa@fmu.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Fukushima Medical University
Institute
Department

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
Email 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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We enrolled 230 patients in this study. Those patients are still under observation period, and the analysis is not performed yet.
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
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 Day
Last follow-up date
2021 Year 08 Month 01 Day
Date of closure to data entry
2021 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
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026755

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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