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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014741
Receipt No. R000017135
Scientific Title Detection of chemotherapy induced cardiac TOXicity in breast cancer study
Date of disclosure of the study information 2014/08/01
Last modified on 2018/09/02

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Basic information
Public title Detection of chemotherapy induced cardiac TOXicity in breast cancer study
Acronym DETOX Study
Scientific Title Detection of chemotherapy induced cardiac TOXicity in breast cancer study
Scientific Title:Acronym 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
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
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
1st name
Middle name
Last name Kenji Nakatsuma
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2014 Year 07 Month 24 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000017135

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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