UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032401 |
|---|---|
| Receipt number | R000036938 |
| Scientific Title | Prospective multicenter study of multimodality imaging to evaluate cardiac function and risk factors in breast cancer patients treated with multidisciplinary treatment |
| Date of disclosure of the study information | 2018/04/27 |
| Last modified on | 2022/04/30 16:58:13 |
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Basic information
Public title
Prospective multicenter study of multimodality imaging to evaluate cardiac function and risk factors in breast cancer patients treated with multidisciplinary treatment
Acronym
Comprehensive heart imaging to evaluate cardiac damage linked with chemotherapy in breast cancer patients
Scientific Title
Prospective multicenter study of multimodality imaging to evaluate cardiac function and risk factors in breast cancer patients treated with multidisciplinary treatment
Scientific Title:Acronym
Comprehensive heart imaging to evaluate cardiac damage linked with chemotherapy in breast cancer patients
Region
| Japan |
Condition
Condition
Breast cancer
Drug-induced cardiomyopathy
Classification by specialty
| Cardiology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clear early diagnostic criteria and risc 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%)
Key secondary outcomes
Incidence 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
1300
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Sugimura |
Organization
Tohoku University
Division name
Department of Cardiovascular Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai city, Miyagi prefecture 980-8574
TEL
022-717-7153
ksugimura@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Sugimura |
Organization
Tohoku University
Division name
Department of Cardiovascular Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai city, Miyagi prefecture 980-8574
TEL
022-717-7153
Homepage URL
ksugimura@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
Hokkaido University Hospital
Dokkyo Medical University Hospital
Nihon University Graduate School of Medicine
St.Luke's International Hospital
Sapporo Medical University Hospital
Osaki Citizen Hospital
Kesen-numa City Hospital
Saka Hospital
Tohoku Medical and Pharmaceutical University Hospital
Tohoku University Hospital
Tohoku Kosai Hospital
Miyagi Cancer Center
Fukushima Medical University
Juntendo University Hospital
Showa University Hospital
Kitasato University Hospital
St. Marianna University School of Medicine
Kanazawa University Hospital
Mie University Hospital
Kyoto University Hospital
Osaka City Hospital
Kobe City Hospital
Kurume University Hospital
Kagoshima University Hospital
JCHO Kurume General Hospital
University Hospital Kyoto Prefectural University of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai city, Miyagi prefecture 980-8574
Tel
022-717-8007
med-kenkyo@grp.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
北海道大学病院（北海道）
札幌医科大学病院（北海道）
気仙沼市立病院（宮城県）
大崎市民病院（宮城県）
東北大学病院（宮城県）
東北公済病院（宮城県）
東北医科薬科大学病院（宮城県）
坂総合病院（宮城県）
福島県立医科大学病院（福島県）
獨協医科大学病院（栃木県）
日本大学医学部付属板橋病院（東京都）
聖路加国際病院（東京都）
順天堂大学医学部附属順天堂医院（東京都）
昭和大学附属病院（東京都）
北里大学附属病院（神奈川県）
聖マリアンナ医科大学病院（神奈川）
金沢大学病院（石川県）
三重大学医学部附属病院（三重県）
京都大学病院（京都府）
京都府立医科大学病院（京都府）
神戸市民病院（兵庫県）
久留米大学病院（福岡県）
JCHO久留米総合病院（福岡県）
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 27 | 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
690
Results
Follow-up period has finished.
Results date posted
| 2020 | Year | 04 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because of data analysis
Date of the first journal publication of results
Baseline Characteristics
Breast cancer patients treated with chemotherapies
Participant flow
Adverse events
none
Outcome measures
Development of CTRCD
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 31 | Day |
Other
Other related information
The patients in our out-patient clinic for cardio-oncology in the Tohoku University Hospital from August 2017 will be registered.
About 700 breast cancer patients has been registrated and follw-up period has finished.
Management information
Registered date
| 2018 | Year | 04 | Month | 27 | Day |
Last modified on
| 2022 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036938
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
