UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020690 |
|---|---|
| Receipt number | R000023867 |
| Scientific Title | Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment |
| Date of disclosure of the study information | 2016/01/21 |
| Last modified on | 2019/08/17 16:18:09 |
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Basic information
Public title
Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment
Acronym
Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment
Scientific Title
Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment
Scientific Title:Acronym
Biomarker evaluation as the cardiotoxic evaluation index in the molecular target drug for breast cancer treatment
Region
| Japan |
Condition
Condition
HER2-positive breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether you can predict cardiotoxic prognosis caused by the treatment with the molecular target drug of the breast cancer using biomarker(high-sensitivity troponin I;hsTnI, high-sensitivity troponin T;hs TnT, B-type natriuretic peptide;BNP)
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cardiotoxicity that was defined according to a standard of CREC(the Cardiac Review and Evaluation Committee of Trastuzumab-associated cardiotoxicity)
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
1)Patients with breast cancer that treatment with antiHER2 medicine is planned
2)By an explanation document, the agreements from a patient to a trial entry are provided
Key exclusion criteria
1)The patient who withdrew an agreement
2)Examination participation of the patients is taken as inappropriate by the medical attendant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ito |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Breast Oncology
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
yito@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ito |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Breast Oncology
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
yito@jfcr.or.jp
Sponsor or person
Institute
Division of Breast Oncology,Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Abbott
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
Ethics Committee of Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
Tel
03-3520-0111
keiko.ohta@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
| 2016 | Year | 01 | Month | 21 | 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
113
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
| 2014 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design : cohort study
Patients : From Nobember 10 2014 to Nobember 10 2016, all that meet the selection criteria in patients who were admitted to our hospital
endopoints:
Patient characteristics
therapy(operation,radiation,chemotherapy)
Perfrmance Status
clinical exams
biomarker, Echocardiography
1)HsTnI, hsTnT, BNP will be measured before chemotherapy and before anti-HER2 therapy, and on the prescribed date.
2)Echocardiography (LVEF, E/e', E/A, DcT) will be measured before chemotherapy and before anti-HER2 therapy, and on the prescribed date.
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2019 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023867
