A Retrospective Multicenter Analysis of PD-L1 expression in Japanese Renal Cell Carcinoma patients

A Retrospective Multicenter Analysis of PD-L1 expression in Japanese Renal Cell Carcinoma patients - A Retrospective Multicenter Analysis of PD-L1 expression in Japanese Renal Cell Carcinoma patients (CMA-Ate004)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034131

Enrollment

600

Registered

2018-10-01

Start date

2019-01-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cell carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactTomoko Kotani

SRL Medisearch Inc. Clinical Research Development 3

tomoko.kotani@miraca.com03-6692-0499

Outcome results