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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000004374 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | renal cell carcinoma | |
Classification by specialty |
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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 | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 100 |
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Name of lead principal investigator |
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Organization | Kobe University Graduate school of Medicine | ||||||
Division name | Department of Urology | ||||||
Zip code | |||||||
Address | 7-5-1,Kusunoki-tyo,Kobe-city, Japan | ||||||
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Name of contact person |
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Organization | Kobe University Graduate school of Medicine | ||||||
Division name | Department of Urology | ||||||
Zip code | |||||||
Address | 7-5-1,Kusunoki-tyo,Kobe-city, Japan | ||||||
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Sponsor | |
Institute | Kobe University Graduate school of Medicine |
Institute | |
Department |
Funding Source | |
Organization | pfizer pharmacology |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
Institutions | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
Other related information | not finished |
Management information | |||||||
Registered date |
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Last modified on |
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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 |