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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038875
Receipt No. R000044332
Scientific Title Prospective single-center study of multimodality imaging and omics data analysis to evaluate cardiac function and risk factors in breast cancer patients treated with chemothrapy
Date of disclosure of the study information 2020/01/01
Last modified on 2020/10/29

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Basic information
Public title Prospective single-center study of multimodality imaging and omics data analysis to evaluate cardiac function and risk factors in breast cancer patients treated with chemothrapy
Acronym CHEACK HEART BC-omics
Scientific Title Prospective single-center study of multimodality imaging and omics data analysis to evaluate cardiac function and risk factors in breast cancer patients treated with chemothrapy
Scientific Title:Acronym CHECK HEART BC-omics
Region
Japan

Condition
Condition Breast cancer Drug-induced cardiomyopathy
Classification by specialty
Cardiology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To clear mechanism and risk factors of cardiotoxicity in breast cancer patients treated with multidisciplinary therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of cardiotoxicity after the treatment for breast cancer(a drop in LVEF of > 10% from baseline and < 53%).
The results of omics data analysis.
Key secondary outcomes ncidence of symptomatic heart failure or any other cardiac event after the treatment for breast cancer.

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 (1)Patients who will receive chemotherapy in medical institutions for clinical trials.
(2)Informed consent in writing.
Key exclusion criteria (1)Patients who are judged irrelevant to this clinical trial by the attending doctor.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Nochioka
Middle name
Last name Kotaro
Organization Tohoku University
Division name Department of Cardiovascular Medicine
Zip code 9808574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai city, Miyagi prefecture 980-8574
TEL 022-717-7153
Email nochioka@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Nochioka
Middle name
Last name Kotaro
Organization Tohoku University
Division name Department of Cardiovascular medicine
Zip code 9808574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai city, Miyagi prefecture 980-8574
TEL 022-717-7153
Homepage URL
Email nochioka@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University IRB
Address 1-2 Seiryo-machi, Aoba-ku, Sendai city, Miyagi prefecture 980-8574
Tel 022-728-4105
Email nochioka@cardio.med.tohoku.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
2020 Year 01 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 Open public recruiting
Date of protocol fixation
2020 Year 01 Month 01 Day
Date of IRB
2020 Year 01 Month 28 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2025 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The patients in our out-patient clinic for cardio-oncology in the Tohoku University Hospital from February 2020 will be registered.

Management information
Registered date
2019 Year 12 Month 13 Day
Last modified on
2020 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044332

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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