UMIN-CTR Clinical Trial

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
Email	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
Email	ksugimura@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	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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036938