UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018948 |
|---|---|
| Receipt number | R000021921 |
| Scientific Title | Study for association with dermatological adverse event induced by molecular targeted drugs and profile of body weigh dispersion |
| Date of disclosure of the study information | 2015/09/08 |
| Last modified on | 2019/03/11 09:31:55 |
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Basic information
Public title
Study for association with dermatological adverse event induced by molecular targeted drugs and profile of body weigh dispersion
Acronym
Association with dermatological adverse event induced by molecular targeted drugs and profile of body weigh dispersion
Scientific Title
Study for association with dermatological adverse event induced by molecular targeted drugs and profile of body weigh dispersion
Scientific Title:Acronym
Association with dermatological adverse event induced by molecular targeted drugs and profile of body weigh dispersion
Region
| Japan |
Condition
Condition
metastatic renal cell cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate association with hand-foot skin reaction induced by multiple-tyrosine kinase inhibitors and profile of despersion of body weight
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference of loading ratio in each planter region before treatment of multiple-tyrosine kinase inhibitors and ideal loading ratio of them in Japanese
Key secondary outcomes
1.
2.
3.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. self agreement
2. ECOG-PS 0-2
3. renal cell carcinoma
4. patients received treatment of sorafenib, sunitinib, or axitinib
Key exclusion criteria
1. hypersensitivity of sorafenib, sunitinib, or axitinib
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yamamoto |
Organization
Kobe University Hospital
Division name
Pharmacy
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-6659
yamakz@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yamamoto |
Organization
Kobe University Hospital
Division name
Pharmacy
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-6659
Homepage URL
yamakz@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Pharmacy, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Pharmacy, Kobe University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
asix co.
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
| 2015 | Year | 09 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 10 | 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
Subscription of subject:
Management information
Registered date
| 2015 | Year | 09 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021921
