UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004374 |
|---|---|
| Receipt number | R000005230 |
| Scientific Title | Identification of serum markers mediating resistance to sunitinib in patients with renal cell carcinoma |
| Date of disclosure of the study information | 2010/10/13 |
| Last modified on | 2010/10/12 18:49:05 |
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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
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
| 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
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
Sponsor or person
Institute
Kobe University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
pfizer pharmacology
Organization
Division
Category of Funding Organization
Profit organization
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 | 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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005230
