UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038875 |
|---|---|
| Receipt number | 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 16:36:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
nochioka@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044332
