RCC-SNPs Ensuring-study for Leading Eligibility of patients in Cytokine Therapy

UMIN ID: UMIN000000731

Registered date:04/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Renal cell carcinoma
• Date of first enrollment: 2006/12/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): interferon-a

Outcome(s)

• Primary Outcome: The correlation between the antitomor effects of interferon-a and SNP allele frequencies of STAT3-2 genes.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: JISG-KC
• Source(s) of Monetary Support: CReS Kyushu