UMIN-CTR Clinical Trial

Basic information
Public title	A Retrospective Multicenter Analysis of PD-L1 expression in Japanese Renal Cell Carcinoma patients
Acronym	A Retrospective Multicenter Analysis of PD-L1 expression in Japanese Renal Cell Carcinoma patients (CMA-Ate004)
Scientific Title	A Retrospective Multicenter Analysis of PD-L1 expression in Japanese Renal Cell Carcinoma patients
Scientific Title:Acronym	A Retrospective Multicenter Analysis of PD-L1 expression in Japanese Renal Cell Carcinoma patients (CMA-Ate004)
Region	Japan

Condition
Condition	renal cell carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare OS in Japanese RCC patients by PD-L1 expression status(IC0 vs IC1/2/3). OS is defined as the time from the initiation date of first line treatment to death due to any cause. PD-L1 expression status is scored by proportion of tumor area covered with any discernible PD-L1 immune cell staining of any intensity.
Basic objectives2	Others
Basic objectives -Others	Secondary objectives 1.To compare OS by PD-L1 expression status (IC0, IC1, IC2, IC3) 2.To compare OS after nephrectomy includes receiving cytoreductive nephrectomy by PD-L1 expression status. 3.To compare time to relapse after nephrectomy by PD-L1 status 4.To Compare treatment duration of first and second line therapy for recurrent or metastatic RCC by PD-L1 status Exploratory objectives To assess immunological exploratory biomarkers and their association with OS and clinical characteristics of RCC.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	OS in PD-L1 negative (IC0) and positive (IC1/2/3) patients. OS is defined as the time from the initiation date of first line treatment to death due to any cause.
Key secondary outcomes	1.OS in each level of PD-L1 expression(IC0, IC1,IC2,IC3), OS is defined as the time from the initiation date of first line treatment to death due to any cause. 2.OS defined as the time from initial nephrectomy includes receiving cytoreductive nephrectomy to death due to any cause in PD-L1negative and positive patients. 3.Time to relapse after radical nephrectomy 4.Treatment duration of first line and second line.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Written informed consent for this study. In the case obtaining written informed consent is difficult due to death, change of address, and so on, the opt-out consent is accepted by giving patients or their relatives notification regarding the usage of their clinical information and surgical samples for the research. 2.Age at nephrectomy>=20 years 3.Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression
Key exclusion criteria	1.Malignancies other than RCC is co-existed during the time from nephrectomy and death. 2.Treatment with anti-CTLA-4 antibody, anti-PD-1/PD-L1 antibodies as first-line therapy for recurrent or metastatic RCC.
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Kaori Middle name Last name Ouch
Organization	Chugai Pharmaceutical Co., Ltd.
Division name	Medical Science Department
Zip code	103-8324
Address	1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo 103-8324, JAPAN
TEL	03-3273-0866
Email	cma-clinicaltrial@chugai-pharm.co.jp

Public contact
Name of contact person	1st name Tomoko Middle name Last name Kotani
Organization	SRL Medisearch Inc.
Division name	Clinical Research Development 3
Zip code	163-1310
Address	Shinjuku I-Land Tower 10F 6-5-1, Nishishinjuku, Shinjuku-ku, Tokyo 163-1310, JAPAN
TEL	03-6692-0499
Homepage URL
Email	tomoko.kotani@miraca.com

Sponsor
Institute	Chugai Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co., Ltd.
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	Non-Profit Organization MINS Institutional Review Board
Address	5-20-9-401, Mita, Minato-ku, Tokyo
Tel	03-6416-1868
Email	npo-mins@j-irb.com

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

北海道大学病院（北海道）、札幌医科大学附属病院（北海道）、弘前大学医学部附属病院（青森県）、岩手医科大学附属病院（岩手県）、筑波大学附属病院（茨城県）、東邦大学医療センター佐倉病院（千葉県）、慶應義塾大学病院（東京都）、東京医科歯科大学医学部附属病院（東京都）日本医科大学付属病院（東京都）、北里大学病院（神奈川県）、横浜市立大学附属病院（神奈川県）、新潟大学医歯学総合病院（新潟県）、富山大学附属病院（富山県）、静岡県立静岡がんセンター（静岡県）、浜松医科大学医学部附属病院（静岡県）、愛知医科大学病院（愛知県）、名古屋大学医学部附属病院（愛知県）、京都大学医学部附属病院（京都府）、大阪市立大学医学部附属病院（大阪府）、大阪大学医学部附属病院（大阪府）、近畿大学医学部附属病院（大阪府）、神戸大学医学部附属病院（兵庫県）、奈良県立医科大学附属病院（奈良県）、岡山大学病院（岡山県）、徳島大学病院（徳島県）、香川大学医学部附属病院（香川県）、九州大学病院（福岡県）、長崎大学病院（長崎県）、熊本大学医学部附属病院（熊本県）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 01 Day

Related information
URL releasing protocol	Unpublished (Not prepared public disclosure)
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007%2Fs10147-021-01993-x
Number of participants that the trial has enrolled	830
Results	American Association for Cancer Research Annual Meeting 2020
Results date posted	2020 Year 07 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 07 Month 21 Day
Baseline Characteristics	Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression
Participant flow	RCC patients who met the eligibility criteria were enrolled. PD-L1 expression status of surgical specimens was measured by central pathology. We analyzed prognostic impact of PD-L1 in the patients who were evaluable of PD-L1 status of surgical specimens
Adverse events	N/A
Outcome measures	OS after first-line therapy
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 09 Day
Date of IRB	2018 Year 07 Month 19 Day
Anticipated trial start date	2019 Year 01 Month 21 Day
Last follow-up date	2019 Year 07 Month 18 Day
Date of closure to data entry	2019 Year 07 Month 18 Day
Date trial data considered complete	2019 Year 09 Month 02 Day
Date analysis concluded	2019 Year 09 Month 27 Day

Other
Other related information	Retrospective study for Japanese Renal cell carcinoma patients. Archived specimens from each hospitals are obtained, then assess PD-L1 status by central laboratory.

Management information
Registered date	2018 Year 09 Month 14 Day
Last modified on	2021 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038888