Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Urologic Neoplasms
Eligibility:
All Genders
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age \> 20, Japanese men and women.
- Patients who have started at least 1 cycle of chemotherapy.
- Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.
- Patients who are diagnosed as stage IV (T4b, any N or any T, N2-3 or M1) UC between January 1st in 2017 and December 31st in 2018.
- Patients who have FFPE primary tumor sample collected after January 1st in 2017. The sample should be collected before any therapies including 1st line treatment in stage IV and therapies in stage III and other stages. It is possible to send sliced undyed section of primary tumor including 1 HE-stained section of same sample in case that patients cannot send FFPE primary tumor block.
Exclusion
- Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.
Key Trial Info
Start Date :
October 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 23 2020
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04052113
Start Date
October 25 2019
End Date
March 23 2020
Last Update
March 1 2021
Active Locations (1)
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1
Research Site
Kyoto, Japan, 606-8507