UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034131 |
|---|---|
| Receipt number | R000038888 |
| Scientific Title | A Retrospective Multicenter Analysis of PD-L1 expression in Japanese Renal Cell Carcinoma patients |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/08/27 14:03:40 |
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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
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
tomoko.kotani@miraca.com
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038888
