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This is a multicenter retrospective study designed to compare overall survival (OS) by PD-L1 expression status in patients with RCC who have received systemic chemotherapy for recurrent or metastatic RCC, to determine whether the prognosis is worse in PD-L1-positive than in PD-L1-negative RCC.
Total 600 RCC surgical specimens will be collected from patients who started systemic chemotherapy for recurrent or metastatic RCC between January 1, 2010 and December 31, 2015 at about 30 participating study sites in Japan.
PD-L1 expression status (IC; immune cell) on tumor-infiltrating immune cells will be evaluated by IHC, and classified by score: IC0 (PD-L1-negative) and IC1, IC2, IC3 (PD-L1-positive). Unless otherwise specified, between-group comparisons will be performed between IC0 and IC1/2/3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full analysis set | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival in PD-L1 negative (IC0) and positive (IC1/2/3) patients. | Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3) | Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause. | Baseline |
| Overall survival after nephrectomy (including cytoreductive nephrectomy) |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University | Nagoya | Aichi-ken | 480-1103 | Japan |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (ClinicalStudyDataRequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html)
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Overall survival is defined the time from nephrectomy (including cytoreductive nephrectomy) to death due to any cause. |
| Baseline |
| Time to recurrence after radical nephrectomy | Time to recurrence after radical nephrectomy is the duration from the day of surgery to diagnosis of recurrent. | Baseline |
| Treatment duration (first-line and second-line therapy) | Treatment duration is the duration from the day1 of systemic therapy for mRCC to the end of the treatment. | Baseline |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |