UMIN-CTR Clinical Trial

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

Renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

YES

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

JISG-KC

Institute

Department

Personal name

Organization

CReS Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2007

Year

06

Month

04

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2007

Year

06

Month

04

Day

Last modified on

2016

Year

12

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000840