Clinical trial · Observational
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
NCT04052113CI-TRIAL-00050372YODOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 to assay PD-L1 expression and next generation sequencer (NGS) assay for tumor mutation burden (TMB).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urologic Neoplasms | Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of PD-L1 in stage IV UC patients in real world setting.
- timeFrame
- Baseline
- description
- Summarize number and calculate ratio of PD-L1 high or low/negative patients, respectively.
Secondary outcomes (3)
- measure
- Prevalence of TMB in stage IV UC patients in real world setting.
- timeFrame
- Baseline
- description
- Calculate median and average of TMB levels. Summarize number and calculate ratio of TMB high or low/negative patients, respectively.
- measure
- OS from start of 1st line treatment in stage IV
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: -Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.
References
Publications (0)
Data not yet available
No reference posted for this study.