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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
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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. 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).

Condition or disease
Urologic Neoplasms

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. 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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study is a multi-center, non-interventional study, and Stage IV UC patients who have received at least 1 cycle of chemotherapy and have archived primary tumor sample collected after January 1st in 2017 will be of the interest. However, the patients who received immune oncology drug as 1st line treatment in stage IV will not be in this study.
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04052113     History of Changes
Other Study ID Numbers: D419BR00014
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by AstraZeneca:
Real world, PD-L1, TMB, Stage IV, urothelial cancer, Japanese
Additional relevant MeSH terms:
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Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms