UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022984
Receipt number R000026423
Scientific Title A cohort study of anthracycline-induced cardiotoxicity
Date of disclosure of the study information 2016/08/01
Last modified on 2022/01/04 16:34:00

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Basic information

Public title

A cohort study of anthracycline-induced cardiotoxicity

Acronym

A cohort study of anthracycline-induced cardiotoxicity

Scientific Title

A cohort study of anthracycline-induced cardiotoxicity

Scientific Title:Acronym

A cohort study of anthracycline-induced cardiotoxicity

Region

Japan


Condition

Condition

All patients scheduled for anthracycline-containing therapy for various kinds of tumors

Classification by specialty

Cardiology Hematology and clinical oncology Breast surgery
Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the incidence of anthracycline-induced cardiotoxicity and find predictive factors markers in cancer patients

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The incidence of cardiotoxicity defined as a reduction in left ventricular ejection fraction (LVEF) >10 percentage points from baseline and <50%

Key secondary outcomes

All cause death, the following cardiac events (cardiac death, acute pulmonary edema, acute coronary syndromes, llife-threatening arrhythmias), the recovery from cadiotoxicity after the initiation of heart failure treatment defined as EF>50%


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Echocardiac examination (before & during anthracycline treatment, after 3, 6, 9, 12, 18, 24 month)

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) malignancy patients in the face of with anthracycline chemotherapy
2) age more than 20 years old
3) EF > 50%
4) life expectancy of > 1year
5) written informed consent

Key exclusion criteria

1) cases with valuvular heart disease, gongenital heart disease, and cardiomyopathy
2) pregnant or lactating women
3) psychotic disorder

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Kazuko
Middle name
Last name Tajiri

Organization

University of Tsukuba Hospital

Division name

Cardiovascular Division

Zip code

305-8576

Address

Amakubo 2-1-1, Tsukuba, Ibaraki

TEL

029-853-3143

Email

ktajiri@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Kazuko
Middle name
Last name Tajiri

Organization

University of Tsukuba Hospital

Division name

Cardiovascular Division

Zip code

305-8576

Address

Amakubo 2-1-1, Tsukuba, Ibaraki

TEL

029-853-3143

Homepage URL


Email

ktajiri@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

University of Tsukuba

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tsukuba Hospital

Address

2-1-1 Amakubo, Tsukuba

Tel

029-853-3914

Email

rinshokenkyu@un.tsukuba.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

筑波大学附属病院(茨城県)、水戸協同病院(茨城県)


Other administrative information

Date of disclosure of the study information

2016 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

500

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

No longer recruiting

Date of protocol fixation

2016 Year 06 Month 30 Day

Date of IRB

2016 Year 07 Month 13 Day

Anticipated trial start date

2016 Year 08 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 07 Month 02 Day

Last modified on

2022 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026423


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name