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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018948
Receipt No. 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

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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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