UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016962
Receipt number R000019686
Scientific Title Prospective observational study to investigate the predictors of trastuzumab induced cardiac toxicity in breast cancer patients with perioperative chemotherapy
Date of disclosure of the study information 2015/04/01
Last modified on 2020/04/07 01:10:47

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Basic information

Public title

Prospective observational study to investigate the predictors of trastuzumab induced cardiac toxicity in breast cancer patients with perioperative chemotherapy

Acronym

predictors of trastuzumab induced cardiac toxicity

Scientific Title

Prospective observational study to investigate the predictors of trastuzumab induced cardiac toxicity in breast cancer patients with perioperative chemotherapy

Scientific Title:Acronym

predictors of trastuzumab induced cardiac toxicity

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Cardiology Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To invesitigate the incidence and predictors of trastuzumab induced cardiac toxicity in breast cancer patients with perioperative chemotherapy

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cardiomyopathy defined as incidence of cardiotoxicity, heart failure admission, and myocardial markers

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients with breast cancer undergoing anthracycline and trastuzumab as perioperative chemotherapy

Key exclusion criteria

Patients unsuitable condition for this study judged by the investigator

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Ishiguro

Organization

Graduate School of Medicine Kyoto Universit

Division name

Department of Target Therapy Oncology

Zip code

606-8507

Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, Japan

TEL

075-751-4950

Email

hishimd@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Moe
Middle name
Last name Tsuda

Organization

Graduate School of Medicine Kyoto Universit

Division name

Breast Surgery

Zip code

606-8507

Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, Japan

TEL

075-751-3660

Homepage URL


Email

moe1985@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Graduate School of Medicine Kyoto University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School of Medicine Kyoto University

Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, Japan

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.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

2015 Year 04 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

50

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

Completed

Date of protocol fixation

2015 Year 03 Month 01 Day

Date of IRB

2015 Year 04 Month 13 Day

Anticipated trial start date

2015 Year 04 Month 13 Day

Last follow-up date

2020 Year 04 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study


Management information

Registered date

2015 Year 03 Month 29 Day

Last modified on

2020 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019686


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name