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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030429
Receipt No. R000034742
Scientific Title Prediction of trastuzumab-induced cardiotoxicity using transthoracic echocardiography and cardiac biomarkers in patients with gastric cancer
Date of disclosure of the study information 2017/12/16
Last modified on 2018/12/17

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Basic information
Public title Prediction of trastuzumab-induced cardiotoxicity using transthoracic echocardiography and cardiac biomarkers in patients with gastric cancer
Acronym Prediction of trastuzumab-induced cardiotoxicity using transthoracic echocardiography and cardiac biomarkers in patients with gastric cancer
Scientific Title Prediction of trastuzumab-induced cardiotoxicity using transthoracic echocardiography and cardiac biomarkers in patients with gastric cancer
Scientific Title:Acronym Prediction of trastuzumab-induced cardiotoxicity using transthoracic echocardiography and cardiac biomarkers in patients with gastric cancer
Region
Japan

Condition
Condition Cancer therapeutics-related cardiac dysfunction
Classification by specialty
Cardiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to predict trastuzumab-induced cardiotoxicity using transthoracic echocardiography and cardiac biomarkers in patients with gastric cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of left ventricular ejection fraction value before and after chemotherapy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction
Patients who receive trastuzumab plus chemotherapy (pyrimidine fluoride drug plus cisplatin) or chemotherapy alone
No previous chemotherapy within 6 months
Prospect of life prognosis more than 3 months
Men or women older than 20 years of age
Written informed consent can be obtained
Key exclusion criteria The investigator's consider unsuitable for registration
Suitable echocardiographic data can not be obtained for diagnostic imaging
Patients can not have clinical examinations due to bad general condition
Patients can not visit the hospital periodically
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atai WATANABE
Organization Cancer Institute Hospital
Division name Department of General Medicine
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo
TEL 03-3520-0111
Email atai.watanabe@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atai WATANABE
Organization Cancer Institute Hospital
Division name Department of General Medicine
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo
TEL 03-3520-0111
Homepage URL
Email atai.watanabe@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 12 Month 16 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood test including cardiac biomarkers, Chest X-ray, electrocardiogram and echocardiography are performed before and after induction of trastuzumab plus chemotherapy (pyrimidine fluoride drug plus cisplatin) or chemotherapy alone.

Management information
Registered date
2017 Year 12 Month 16 Day
Last modified on
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034742

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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