UMIN-CTR Clinical Trial

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
Scientific Title:Acronym
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
Last 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
Email	yamakz@med.kobe-u.ac.jp

Public contact
1st 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
Email	yamakz@med.kobe-u.ac.jp

Sponsor
Institute	Department of Pharmacy, Kobe University Hospital
Institute
Department

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
Email

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
Oucome 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021921