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 | 2025/03/19 01:55:31 |
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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
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
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
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
Terminated
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
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019686
