UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016962
Receipt No. 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 2019/04/08

* 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 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
Institute Graduate School of Medicine Kyoto University
Institute
Department

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
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
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
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.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


Contact us.