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

NCT04052113 | Completed

• 1 other identifier: D419BR00014
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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).

Conditions

Urologic Neoplasms

Keywords

Real world, PD-L1, TMB, Stage IV, urothelial cancer, Japanese

Outcome Measures

Primary Outcomes (1)

• Prevalence of PD-L1 in stage IV UC patients in real world setting.

  Summarize number and calculate ratio of PD-L1 high or low/negative patients, respectively.

  Baseline

Secondary Outcomes (3)

• Prevalence of TMB in stage IV UC patients in real world setting.

  Baseline

• OS from start of 1st line treatment in stage IV

  2 years

• PFS from start of 1st line treatment in stage IV

  18 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Kyoto, 606-8507, Japan

Location

Related Links

• Redacted Synopsis

MeSH Terms

Conditions

Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 9, 2019
• Study Start: October 25, 2019
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)