UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detection of chemotherapy induced cardiac TOXicity in breast cancer study
Title of the study (Brief title)	DETOX Study
Region	Japan

Condition
Condition	Patients with breast cancer undergoing anthracycline chemotherapy
Classification by specialty	Medicine in general Cardiology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the incidence and predictors of cardiotoxicity with anthracycline chemotherapy in patients with breast cancer and to evaluate whether cardiac biomarkers predict early myocardial damage or onset of heart failure in these patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of cardiotoxicity defined as a reduction of left ventricular ejection fraction >=5% to <55% with symptoms of heart failure or an asymptomatic reduction of left ventricular ejection fraction >=10% to <55%.
Key secondary outcomes	cardiac biomarkers echocardiographic parameters symptoms and signs of heart failure heart failure admission usage of cardioprotective drugs

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with breast cancer undergoing anthracycline chemotherapy in the Kyoto University Hospital from 2014 to 2015.
Key exclusion criteria	Patients who declined to participate in the study.
Target sample size	100

Research contact person
Name of lead principal investigator	Takeshi Kimura
Organization	Kyoto University Hospital
Division name	Department of Cardiovascular Medicine
Address	54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Kyoto, Japan.
TEL	0757514255
Email	taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Kenji Nakatsuma
Organization	Kyoto University Hospital
Division name	Department of Cardiovascular Medicine
Address	54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Kyoto, Japan.
TEL	0757514255
Homepage URL
Email	kj1004@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department

Funding Source
Organization	Abbott Japan
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto University Cancer Center, Kyoto University Hospital
Name of secondary funｄer(s)

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	2014 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 24 Day
Anticipated trial start date	2014 Year 08 Month 18 Day
Last follow-up date	2017 Year 02 Month 14 Day
Date of closure to data entry	2017 Year 05 Month 01 Day
Date trial data considered complete	2018 Year 04 Month 01 Day
Date analysis concluded	2018 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Patient enrollment: July 2014-June 2016

Management information
Registered date	2014 Year 08 Month 01 Day
Last modified on	2018 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017135