Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer (YODO)
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|ClinicalTrials.gov Identifier: NCT04052113|
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
|Condition or disease|
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected from each site and conduct programmed cell death 1 ligand 1 (PD-L1) assay and next generation sequencer (NGS) assay for tumor mutation burden (TMB). Based on these data, prevalence of PD-L1, TMB and overall survival (OS), progression free survival (PFS) from start of 1st line treatment in stage IV will be assessed.
In this study, 150 patients will be enrolled from approximately 30 sites in Japan. The patients should have received at least 1 cycle of chemotherapy and never receive immune oncology drug as 1st line treatment in stage IV. The patients will be enrolled continuously from the 1st patient who is enrolled in this study until target number of patients in each site.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer|
|Estimated Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
- Prevalence of PD-L1 in stage IV UC patients in real world setting. [ Time Frame: Baseline ]Summarize number and calculate ratio of PD-L1 high or low/negative patients, respectively.
- Prevalence of TMB in stage IV UC patients in real world setting. [ Time Frame: Baseline ]Calculate median and average of TMB levels. Summarize number and calculate ratio of TMB high or low/negative patients, respectively.
- OS from start of 1st line treatment in stage IV [ Time Frame: 2 years ]Median OS and OS rate at 12 months, 18 months and 24 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
- PFS from start of 1st line treatment in stage IV [ Time Frame: 18 months ]Median PFS and PFS rate at 6months, 12months and 18 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052113
|Contact: AstraZeneca Clinical Study Information Centerfirstname.lastname@example.org|