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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000731
Enrollment
150
Registered
2007-06-04
Start date
2006-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal cell carcinoma

Interventions

interferon-a

Sponsors

JISG-KC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
The correlation between the antitomor effects of interferon-a and SNP allele frequencies of STAT3-2 genes.

Countries

Japan

Contacts

Public ContactMasatoshi Eto

Graduate School of Medical Sciences, Kyushu University Department of Urology

etom@uro.med.kyushu-u.ac.jp092-642-5603

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026