UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003071 |
|---|---|
| Receipt number | R000003726 |
| Scientific Title | Financial support for off-label prescription in patients with severe adverse drug reaction due to cancer chemotherapy |
| Date of disclosure of the study information | 2010/01/31 |
| Last modified on | 2017/07/30 07:11:24 |
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Basic information
Public title
Financial support for off-label prescription in patients with severe adverse drug reaction due to cancer chemotherapy
Acronym
How to support financially for off-label prescription
Scientific Title
Financial support for off-label prescription in patients with severe adverse drug reaction due to cancer chemotherapy
Scientific Title:Acronym
How to support financially for off-label prescription
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Medicine in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reimburse medical cost of off-label prescription severe adverse chemotherapy drug reaction when patients did not use public medical insurance
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse drug reactions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medical cost payment
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
Male and Female
Key inclusion criteria
Breast cancer patients
Reducing chemotherapy dose may affect clinical efficacy
Informed consent
Key exclusion criteria
Contraindication for medication
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ishiguro |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Target Therapy Oncology
Zip code
Address
54 Syogoinkawahara-machi, Sakyo-ku, Kyoto-city
TEL
075-751-4950
hkkishi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Okuda |
Organization
kyoto University Hospital
Division name
Department of Breast Surgery
Zip code
Address
54 Syogoinkawahara-machi, Sakyo-ku, Kyoto-city
TEL
075-751-3660
Homepage URL
oku@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical Research Fund
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 01 | Month | 31 | 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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 21 | Day |
Last modified on
| 2017 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003726
| 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 |
