UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037739 |
|---|---|
| Receipt number | R000042791 |
| Scientific Title | Identification of gene polymorphisms that predict the efficacy and safety of nivolumab treatment for renal cancer |
| Date of disclosure of the study information | 2019/08/20 |
| Last modified on | 2020/08/19 15:07:57 |
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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
Interventions/Control_1
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.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
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
shiota@uro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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
(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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042791
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
