UMIN-CTR Clinical Trial

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
Email	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
Email	ckomiyama88@gmail.com

Sponsor
Institute	Toranomon Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050120