UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043889 |
|---|---|
| Receipt number | R000050120 |
| Scientific Title | Multicenter prospective observational study of Antineoplastic cardiotoxicity and Chemotherapy-related Cardiac Dysfunction |
| Date of disclosure of the study information | 2021/04/12 |
| Last modified on | 2021/04/11 20:18:33 |
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Basic information
Public title
Multicenter prospective observational study of Antineoplastic cardiotoxicity and Chemotherapy-related Cardiac Dysfunction
Acronym
Multicenter prospective observational study of Antineoplastic cardiotoxicity and Chemotherapy-related Cardiac Dysfunction
Scientific Title
Multicenter prospective observational study of Antineoplastic cardiotoxicity and Chemotherapy-related Cardiac Dysfunction
Scientific Title:Acronym
Multicenter prospective observational study of Antineoplastic cardiotoxicity and Chemotherapy-related Cardiac Dysfunction
Region
| Japan |
Condition
Condition
Hematological tumors treated with CHOP therapy
Classification by specialty
| Cardiology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine indicators for early detection and intervention of myocardial damage related to anticancer drug therapy
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Onset of CTRCD
Changes in echocardiographic findings before and after the start of chemotherapy
Key secondary outcomes
Development of heart failure
Cardiovascular events
All deaths
Cardiovascular death
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
Patients 20 years of age or older who are scheduled to receive chemotherapy (CHOP, R-CHOP, G-CHOP) including anthracycline anticancer agents at the Department of Hematology of Toranomon Hospital, Kameda General Hospital, or St. Luke's International Hospital
Patients with no history of cardiac disease (heart failure, coronary artery disease, cardiomyopathy, arrhythmia, post-valvular surgery, post-implantation cardiac device, congenital heart disease)
Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria
Patients with LVEF <50% diagnosed by echocardiography
Those judged unsuitable by the physician in charge
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takahide |
| Middle name | |
| Last name | Kodama |
Organization
Toranomon Hospital
Division name
Cardiovascular Center
Zip code
105-8470
Address
Toranomon 2-2-2, Minato-Ku, Tokyo, Japan
TEL
03-3588-1111
kodak.circ@gmail.com
Public contact
Name of contact person
| 1st name | Chinatsu |
| Middle name | |
| Last name | Komiyama |
Organization
Toranomon Hospital
Division name
Cardiovascular Center
Zip code
105-8470
Address
Toranomon 2-2-2, Minato-Ku, Tokyo, Japan
TEL
03-3588-1111
Homepage URL
ckomiyama88@gmail.com
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kameda General Hospital
St. Luke's International Hospital
Juntendo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital
Address
Toranomon 2-2-2, Minato-Ku, Tokyo, Japan
Tel
03-3588-1111
ckomiyama88@gmail.com
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
| 2021 | Year | 04 | Month | 12 | 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
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2021 | Year | 04 | Month | 11 | Day |
Last modified on
| 2021 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050120
| Research Plan | |
|---|---|
| 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 |
