UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030429 |
|---|---|
| Receipt number | 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 | 2024/01/07 15:15:19 |
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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 | Atai |
| Middle name | |
| Last name | WATANABE |
Organization
Cancer Institute Hospital
Division name
Department of General Medicine
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
atai.watanabe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Atai |
| Middle name | |
| Last name | WATANABE |
Organization
Cancer Institute Hospital
Division name
Department of General Medicine
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
Homepage URL
atai.watanabe@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Institute
Department
Personal name
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
Cancer Institute Hospital
Address
3-8-31 Ariake, Koto-ku, Tokyo
Tel
03-3520-0111
med.shinsa@jfcr.or.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
| 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
48
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
| 2017 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 30 | Day |
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
| 2024 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034742
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
