UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058031 |
|---|---|
| Receipt number | R000065963 |
| Scientific Title | A single-center prospective observational study on cardiovascular complications associated with anthracycline-based anticancer agents, focusing on doxorubicin |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/05/30 21:06:44 |
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Basic information
Public title
A single-center prospective observational study on cardiovascular complications associated with anthracycline-based anticancer agents, focusing on doxorubicin
Acronym
DC-Heart Study (Doxorubicin and Cardiovascular Heart Study)
Scientific Title
A single-center prospective observational study on cardiovascular complications associated with anthracycline-based anticancer agents, focusing on doxorubicin
Scientific Title:Acronym
DC-Heart Study (Doxorubicin and Cardiovascular Heart Study)
Region
| Japan |
Condition
Condition
doxorubicin cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the incidence of cardiomyopathy in patients administered doxorubicin.
Basic objectives2
Others
Basic objectives -Others
Secondary endpoints will include evaluating predictors of cardiotoxicity and the impact on prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will investigate the incidence of doxorubicin-induced cardiomyopathy, divide patients into those who developed doxorubicin-induced cardiomyopathy and those who did not, and exploratory study the correlation with patient background, echocardiographic findings, and blood test findings.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria (All of the following must be met):
1)Individuals aged 16 years or older at the time of obtaining informed consent
2)No restrictions based on sex
3)Patients scheduled to receive doxorubicin-based chemotherapy for malignant lymphoma in the Third Department of Internal Medicine at Yamaguchi University Hospital
4)Patients who have undergone, or are scheduled to undergo, echocardiography within six months prior to the initial administration of doxorubicin
5)Patients (or their legally authorized representatives) who have received sufficient explanation regarding participation in this study and have provided written informed consent based on adequate understanding and voluntary agreement
Key exclusion criteria
1)Patients with a history of prior treatment with anthracycline-based anticancer agents
2)Patients who, prior to the initial administration of doxorubicin, have a left ventricular ejection fraction (LVEF) of less than 50%, or exhibit symptoms suggestive of heart failure according to the Framingham criteria
3)Patients deemed unsuitable for participation in this study by the principal investigator or co-investigators for any other reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihide |
| Middle name | |
| Last name | Nakamura |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Cardiology, Department of Medicine and Clinical Science
Zip code
7558505
Address
1-1-1 Minamikogushi, Ube City, Yamaguchi Prefecture, Japan
TEL
0836222248
yoshi44@yamagucgi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihide |
| Middle name | |
| Last name | Nakamura |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Division of Cardiology, Department of Medicine and Clinical Science
Zip code
7550049
Address
minami-kogushi1-1-1, Ube, Yamaguchi, Japan
TEL
0836222248
Homepage URL
yoshi44@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Yoshihide Nakamura
Funding Source
Organization
Yamaguchi University
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
Center for clinical research. Yamaguchi University Hospital
Address
1-1-1 Minamikogushi, Ube City, Yamaguchi Prefecture, Japan
Tel
0836-22-2428
me223@yamaguchi-u.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
| 2025 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study participation period will be from the time of obtaining consent to the study until six months after the final chemotherapy treatment, and is expected to be approximately 12 months per person.
Management information
Registered date
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065963
