UMIN-CTR Clinical Trial

Basic information
Public title	Identification of serum markers mediating resistance to sunitinib in patients with renal cell carcinoma
Acronym	Identification of serum markers mediating resistance to sunitinib in patients with renal cell carcinoma
Scientific Title	Identification of serum markers mediating resistance to sunitinib in patients with renal cell carcinoma
Scientific Title:Acronym	Identification of serum markers mediating resistance to sunitinib in patients with renal cell carcinoma
Region	Japan

Condition
Condition	renal cell carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to identify serum markers associated with resistant phenotype to sunitinib in patients with metastatic RCC in order to develop the precise system for predicting the probability of the acquired resistant phenotype to sunitinib in patients with RCC during treatment with this agent.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	 Before and during treatment with sunitinib, measure serum levels of several molecules (E-cadherin, N-cadherin, fibronectin, MMP-2, MMP-3, MMP-9, MT-MMP-1, TIMP-1, TIMP-2, clusterin, bFGF, uPA and uPAR), which have been shown to be regulated by activated p44/42 MAPK and Akt and to be involved in the acquisition of an EMT phenotype in our preliminary experiments, in patients with metastatic RCC by sandwich enzyme-linked immunosorbent assay (ELISA) kits.
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
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically confirmed metastatic RCC with a component of clear cell histology. Presence of measurable disease; that is, at least 1 metastatic tumor mass that can be accurately measured in at least 1 dimension over 10 mm with conventional radiological modalities, such as computed tomography and magnetic resonance imaging. Age of over 20 years. ECOG performance status of 0 or 1. Life expectancy of over 12 weeks
Key exclusion criteria	Prior use of sunitinib Seizure disorder, evidence of brain metastases, spinal cord compression or carcinomatous meningitis. Active bacterial, fungal or viral infection. History of malignancy other than RCC except for those treated with curative intent with no evidence of disease for at least 2 years. Other severe acute or chronic medical condition.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masato Fujisawa
Organization	Kobe University Graduate school of Medicine
Division name	Department of Urology
Zip code
Address	7-5-1,Kusunoki-tyo,Kobe-city, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Kobe University Graduate school of Medicine
Division name	Department of Urology
Zip code
Address	7-5-1,Kusunoki-tyo,Kobe-city, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Kobe University Graduate school of Medicine
Institute
Department

Funding Source
Organization	pfizer pharmacology
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
Organization
Address
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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 10 Month 13 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
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2010 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	not finished

Management information
Registered date	2010 Year 10 Month 12 Day
Last modified on	2010 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005230

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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