An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.

Study Overview
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Brief Summary
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The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.

Detailed Description
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The primary objective of this observational study is: •To investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients. High PD-L1 expression is defined as ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. Note: PD-L1 High (>=25% tumor cell membrane positivity for PD-L1 or 1) IF IC area >1%: >=25% tumor associated immune cell positivity for PD-L1; 2) If IC area=1%: 100% tumor associated immune cell positivity for PD-L1). PD-L1 Low if criteria not met for PD-L1 High. The second objectives of this observational study are: To investigate the PD-L1 expression profile in TC or IC in Chinese MIUBC patients. To assess the concordance of PD-L1 testing results generated from the hospital labs with those from the central lab. To observe the initial treatment pattern for MIUBC patients in usual clinical practice in China. To observe 2-year OS of the Chinese MIUBC patients. The exploratory objectives of this observational study are: To explore the relationship between the demographic characteristics and expression of PD-L1 and other exploratory biomarkers including immune cell (IC) subset CD8+ T cells and tumor mutation burden (TMB). To explore the relationship between OS and the demographic characteristics as well as the expression of biomarkers. To explore the relationship between PD-L1 and TMB, PD-L1 and CD8 positive T cell respectively.

Official Title
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An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation of Initial Treatment Pattern and Overall Survival in the Chinese Muscle Invasive Urothelial Bladder Carcinoma Patients.

Conditions
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Urinary Bladder Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years at the time of screening. Be able and willing to sign the informed consent form (ICF); Patients with histologically or cytologically documented, muscle invasive urothelial carcinoma (ie., T2 toT4, any N, any M) of Bladder, who have not been previously treated with any systemic chemotherapy, radiotherapy, investigational product, or biologic therapy for cancer treatment. For PD-L1 testing by IHC assay, all patients must be able to provide a newly acquired tumor sample within 60 days before enrollment by cystectomy, transurethral resection or biopsy. Samples with limited tumor content and fine needle aspirate specimens are not acceptable. Specimens from metastatic bone lesions are typically unacceptable unless there is a significant soft tissue component. Exclusion Criteria: Prior acquiring tissuetumor samples exposure to immune-mediated therapy (including Bacillus Calmette Guerin), including but not limited to, any anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines. Any concurrent chemotherapy, investigational product, or biologic therapy for cancer treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevalence of High PD-L1 expression in the MIUBC patients | Tumor tissue will be collected from all eligible patients who sign the ICF. Samples will be tested for PD-L1 expression status. | Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with different PD-L1 expression level | Proportion of patients with different PD-L1 expression level | Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing. | 
| PD-L1 testing concordance between central lab and hospital labs | PD-L1 testing concordance between central lab and hospital labs | Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing. | 
| Distribution percent of different treatment approaches | Distribution percent of different treatment approaches | enrollment visit | 
| 2-year OS | follow up for OS up to 2 years from the baseline | From enrollment to OS, up to 2 years |