UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000731
Receipt No. R000000840
Scientific Title RCC-SNPs Ensuring-study for Leading Eligibility of patients in Cytokine Therapy
Date of disclosure of the study information 2007/06/04
Last modified on 2016/12/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title RCC-SNPs Ensuring-study for Leading Eligibility of patients in Cytokine Therapy
Acronym RCC-SELECT
Scientific Title RCC-SNPs Ensuring-study for Leading Eligibility of patients in Cytokine Therapy
Scientific Title:Acronym RCC-SELECT
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To confirm the correlation between the antitumor effects of interferon-a and SNPs of STAT3-2, STAT3-0, SOCS3-1, IL4R-34, PTGS1-3, PTGS1-4, PTGS1-5, PTGS2-12, IRF2-67, ICSBP-38, TAP2-5 genes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The correlation between the antitomor effects of interferon-a and SNP allele frequencies of STAT3-2 genes.
Key secondary outcomes 1)The correlation between the antitumor effects of interferon-a and SNP allele frequencies of 10 genes(STAT3-0, SOCS3-1, IL4R-34, PTGS1-3, PTGS1-4, PTGS1-5, PTGS2-12, IRF2-67, ICSBP-38, TAP2-5).
2)The relativities between PFS, TTP, OS and CSS with SNP allele frequencies of STAT3-2, STAT3-0, SOCS3-1, IL4R-34, PTGS1-3, PTGS1-4 ,PTGS1-5, PTGS2-12, IRF2-67, ICSBP-38 and TAP2-5 genes.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 interferon-a
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 1)ECOG performance status of 0 to 1
2)Subjects with histologically or cytologically confirmed, advanced RCC
3)Subjects with nephrectomy
4)Life expectancy of at least 3 months at the date of informed consents
5)Adequate functions of major organs
6)Adequate hepatic function (AST and ALT levels < 3 times the ULN)
7)Subjects without serious electrocardiogram abnormalities
8)Subjects with written, signed, dated, and witnessed IRB/IEC approved ICF
Key exclusion criteria 1)Subjects using Sho-saiko-to
2)Subjects with autoimmunehepatitis
3)Known hypersensitivity to interferon
4)Known hypersensitivity to biologics, such as vaccines
5)Myocardial infarction within the previous 12 months
6)Previous history of renal failure
7)Diabetes mellitus with retinopathy, nephropathy, neuropathy, or insulin-dependency
8)Active acute or chronic infection or serious intercurrent illness
9)Liver cirrhosis
10)Severe mental disorder, such as severe depression
11)Pregnant women, or women who have a possibility of pregnancy
12)Prior interferon-a treatment within 6 months before informed consent
13)CNS metastases
14)Subjects without mesurable disease
15)Any other major illness that, in the investigator's judgement, will substantially increase the risk associated with the subject's participation in this study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Naito, and Osamu Ogawa
Organization Graduate School of Medical Sciences, Kyushu University and Graduate School of Medicine, Kyoto University
Division name Department of Urology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan, and 54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 092-642-5603
Email naito@uro.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Eto
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Urology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan,
TEL 092-642-5603
Homepage URL
Email etom@uro.med.kyushu-u.ac.jp

Sponsor
Institute JISG-KC
Institute
Department

Funding Source
Organization CReS Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization japan

Other related organizations
Co-sponsor
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
2007 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2006 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2006 Year 12 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 06 Month 04 Day
Last modified on
2016 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000840

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.