An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.
POLARIS
1 other identifier
observational
248
1 country
17
Brief Summary
The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedStudy Start
First participant enrolled
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2023
CompletedMarch 27, 2024
March 1, 2024
2.9 years
February 9, 2018
March 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Distribution percent of different treatment approaches
enrollment visit
2-year OS
From enrollment to OS, up to 2 years
Other Outcomes (3)
The prevalence of PD-L1 expression by subgroups
enrollment visit
OS by subgroups
from enrollment to OS, up to 2 years
Simple correlation coefficients among biomarkers
enrollment visit
Eligibility Criteria
Patients with a new diagnosis of MIUBC
You may qualify if:
- 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 (see National Comprehensive Cancer Network \[NCCN\] Bladder Cancer Guidelines), who had 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 were 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 were not acceptable. Specimens from metastatic bone lesions were typically unacceptable unless there was a significant soft tissue component. The tumor specimen submitted to establish PD-L1 status should be of sufficient quantity to allow for PD-L1 IHC analyses and was preferred in FFPE blocks.
You may not qualify if:
- Prior acquiring tumor tissue 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, therapeutic anticancer vaccines.
- Any concurrent chemotherapy, investigational product, or biologic therapy for cancer treatment. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent was acceptable (eg, local surgery or radiotherapy).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (17)
Research Site
Beijing, 100034, China
Research Site
Beijing, 100730, China
Research Site
Changchun, 130021, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610041, China
Research Site
Guangzhou, 510060, China
Research Site
Guangzhou, 510120, China
Research Site
Hangzhou, 310014, China
Research Site
Jinan, 250012, China
Research Site
Meizhou, China
Research Site
Nanjing, 2100008, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200072, China
Research Site
Shenyang, 110001, China
Research Site
Wuhan, CN-430030, China
Research Site
Xiamen, 361003, China
Research Site
Zhengzhou, 450052, China
Related Links
Biospecimen
the study will collect sections for certain testing following the priority: PD-L1 (3 sections) \> CD8 (2 sections) \> TMB (6 sections). The minimal required sections number is 3, specially for PD-L1 testing.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liqun ZHOU, doctor
Peking University First Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2018
First Posted
February 15, 2018
Study Start
May 18, 2020
Primary Completion
March 27, 2023
Study Completion
March 27, 2023
Last Updated
March 27, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
Chinese Laws and Regulations don't allow