UMIN-CTR Clinical Trial

Basic information
Public title	Identification of gene polymorphisms that predict the efficacy and safety of nivolumab treatment for renal cancer
Acronym	SNiP-RCC
Scientific Title	Identification of gene polymorphisms that predict the efficacy and safety of nivolumab treatment for renal cancer
Scientific Title:Acronym	SNiP-RCC
Region	Japan

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

Objectives
Narrative objectives1	To identify genetic polymorphisms that predict the efficacy and safety of nivolumab treatment for renal cancer by genome-wide analysis on single-nucleotide polymorphism (SNP).
Basic objectives2	Others
Basic objectives -Others	To carry out genome-wide SNP analysis of genome DNA extracted from blood specimen using Japonica array.
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	SNPs that correlate with tumor response to nivolumab
Key secondary outcomes	SNPs that correlate with progression , treatment continuation and overall survival in nivolumab treatment SNPs that correlate with adverse events in nivolumab treatment

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who were treated or are planned to be treated with nivolumab for advanced renal cancer 2.Patients diagnosed with clear cell carcinoma pathologically 3.Patients with at least one measurable lesion according to RECIST v1.1 criteria 4.Patients who fully understand this research plan and can give their consent 5.Japanese people over 20 years of age at the time of consent acquisition
Key exclusion criteria	1.non-Japanese patients 2.Patients in whom the evaluation of response rate according to RECIST ver.1.1 is not carried out within 24 weeks after the start of treatment 3.Patients who received nivolumab as first line treatment 4.Patients who co-administered with drugs for renal cancer other than nivolumab 5.Patients who are judged inappropriate for participation in this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masatoshi Middle name Last name Eto
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Urology
Zip code	812-8582
Address	3-1-1 Maidashi Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5601
Email	etom@uro.med.kyushu-u.ac.jp

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

Sponsor
Institute	Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	(Not for public release)Entered
Address	(Not for public release)Entered
Tel	(Not for public release)Entered
Email	(Not for public release)Entered

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

北海道大学大学院医学研究科（北海道）、札幌医科大学医学部（北海道）、弘前大学大学院医学研究科（青森県）、岩手医科大学医学部（岩手県）、山形大学医学部（山形県）、新潟大学大学院医歯学総合研究科（新潟県）、慶應義塾大学医学部（東京都）、防衛医科大学校（埼玉県）、浜松医科大学医学部（静岡県）、名古屋大学大学院医学系研究科（愛知県）、京都大学大学院医学研究科（京都府）、大阪大学大学院医学系研究科（大阪府）、近畿大学医学部（大阪府）、奈良県立医科大学（奈良県）、神戸大学大学院医学研究科（兵庫県）、広島市立安佐市民病院（広島県）、山口大学大学院医学系研究科（山口県）、徳島大学大学院医歯薬学研究部（徳島県）、国立病院機構四国がんセンター（愛媛県）、九州大学大学院医学研究院（福岡県）、熊本大学大学院生命科学研究部（熊本県）、長崎大学大学院医歯薬学総合研究科（長崎県）、宮崎大学医学部（宮崎県）、鹿児島大学大学院医歯学総合研究科（鹿児島県）

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Baseline Characteristics
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Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 24 Day
Date of IRB	2019 Year 08 Month 19 Day
Anticipated trial start date	2019 Year 09 Month 06 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1.Extraction of DNA from blood specimen. 2. SNP analysis using Japonica array. 3.Individual SNP analysis using PCR method. 4.Statistical analysis of correlation with clinical information.

Management information
Registered date	2019 Year 08 Month 20 Day
Last modified on	2020 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042791